Job Summary:

• Perform selected data entry of summary forms and questionnaires according to protocol timelines
• Run programmed queries to monitor and evaluate study progress
• Make recommendations of queries based on findings from the data to verify data entry accuracy
• Report periodically to the full project team(s) of interviewing/data tech status of study
• Maintain files of all study materials and non-computer information, including source documents
• Participate in the development of interviewing guidelines
• Recommend new methods for collection and documentation of data
• Perform other related duties incidental to the work described above

Skills on Resume:

• Data Entry (Hard Skills)
• Query Evaluation (Hard Skills)
• Data Accuracy (Hard Skills)
• Status Reporting (Soft Skills)
• File Maintenance (Hard Skills)
• Guideline Development (Soft Skills)
• Method Recommendation (Soft Skills)
• Related Duties (Soft Skills)

Job Summary:

• Review and track clinical trial budgets, invoices, and related financial documentation activities
• Assist with Financial reconciliation for clinical studies
• Review clinical study invoices against data entry and resolve any discrepancies with vendors
• Maintain communication and follow up with vendors on payment related activities
• Complete contract request forms for Legal department
• May assist with administrative support activities
• Assist with maintaining relevant tracking tools and other internal processes
• Classify documents according to the standardized TMF Reference Model.
• Enter required document metadata in an electronic TMF.
• Document and track trial document findings through resolution.

Skills on Resume:

• Budget Tracking (Hard Skills)
• Financial Reconciliation (Hard Skills)
• Invoice Review (Hard Skills)
• Vendor Communication (Soft Skills)
• Contract Requests (Hard Skills)
• Administrative Support (Soft Skills)
• Tool Maintenance (Hard Skills)
• Document Classification (Hard Skills)

Job Summary:

• Ensure all relevant documents are uploaded into the Electronic Trial Master File (eTMF).
• Manage the exchange of TMF documents with external service providers
• Perform periodic reviews and QC of the Trial Master File.
• Provide applicable essential documents to Regulatory for submission to the FDA.
• Serve as a liaison and resource for investigational sites.
• Participate in Site Initiation Visits and Co-monitoring Visits
• Additional Operations activities may be assigned as appropriate.
• Travel as required to carry out responsibilities.
• Participate in the development, review and implementation of departmental SOPs and processes.

Skills on Resume:

• eTMF Management (Hard Skills)
• Document Exchange (Hard Skills)
• QC Reviews (Hard Skills)
• Regulatory Submission (Hard Skills)
• Site Liaison (Soft Skills)
• Site Visits (Soft Skills)
• Operations Support (Soft Skills)
• SOP Development (Hard Skills)

Job Summary:

• Coordinate and attend study team meetings, take, distribute, and file meeting minutes.
• Manage deliverables, navigate changing priorities and communicate any changes.
• Overall management of the Trial Master Files (internal and CROs) including managing set-up, maintenance, and periodic QC. 
• Manage the GCO internal document filings and tracking.
• Coordinate tracking of clinical supply shipments, reviews and/or approve study documentation including essential document packets, study plans, informed consent forms
• Professionally interact and communicate with internal departments (Legal, Regulatory, Safety, etc.), CROs, and external vendors.
• Maintain knowledge and act as team super-user or subject matter expert for related systems and processes
• Provide presentations, training, and support to CTA team, provide updates to applicable CTA resources 
• May train other CTA staff and act as lead for work performed by CTA staff.
• Requires strong attention to detail in composing and/or proofreading and/or approving study materials, establishing priorities, scheduling, and meeting deadlines.

Skills on Resume:

• Meeting Coordination (Soft Skills)
• Deliverable Management (Hard Skills)
• TMF Oversight (Hard Skills)
• Document Tracking (Hard Skills)
• Supply Coordination (Hard Skills)
• Vendor Communication (Soft Skills)
• System Expertise (Hard Skills)
• Training Leadership (Soft Skills)

Job Summary:

• Assist with documents during study start-up including cdas and ctas
• Assist with review of regulatory documents and support irb/ec submissions
• Assist in the organization of investigator meetings
• File essential documents and maintain sponsor documentation
• Verify investigator payment details submitted for payment by Cros for studies where Cros are responsible for this activity
• Support clinical department and/or specific CTM with meetings, including preparation of agendas and minutes and tracking action items
• Support with distribution and tracking of clinical trial supplies
• Perform periodic trial master file quality control checks through the course of the study, for accuracy, quality and completeness
• Verify tracking and reporting study metrics including screening and enrollment, study start-up, and data cleaning
• Provide administrative support for study team members, including organization of meetings (via teams or face-to-face), generation of meeting minutes
• Proactively signal and initiate opportunities for improvement
• Facilitate resolution of study-related issues through communication with investigator site personnel and clinical trial vendors, including central laboratories, cros, other external service providers

Skills on Resume:

• Document Assistance (Hard Skills)
• Regulatory Support (Hard Skills)
• Meeting Organization (Soft Skills)
• Document Maintenance (Hard Skills)
• Payment Verification (Hard Skills)
• Meeting Support (Soft Skills)
• Supply Tracking (Hard Skills)
• Quality Control (Hard Skills)

Job Summary:

• Provide general administrative support to the Clinical team and assistance to the Clinical Operations Project Manager(s)
• Assists the Clinical Operations Project Managers with Sponsor oversight, study-specific documentation review, and quality control, including review of Informed Consent, study plans, study reference manuals, database, etc.
• Assist the Clinical team in the completion of all required tasks to meet departmental and project goals
• Assist the Clinical operations Project Manager(s) with Sponsor oversight of eTMF periodic audit and findings resolution
• Support management of third-party vendors
• Assist with the creation and maintenance of study metrics trackers, tools, and reports
• Track the conduct of the trial, track and oversee progress and status, including study startup, monitoring frequency, prompt site issue resolution, TMF maintenance, drug supply management
• Attends internal and external team meetings/teleconferences and generates meeting agendas and minutes
• Assist with the tracking and distribution of safety reports
• Assist with customization of Confidential Disclosure Agreement, clinical site contracts & budget

Skills on Resume:

• Administrative Support (Soft Skills)
• Documentation Review (Hard Skills)
• Task Completion (Hard Skills)
• Audit Oversight (Hard Skills)
• Vendor Management (Hard Skills)
• Metrics Tracking (Hard Skills)
• Trial Monitoring (Hard Skills)
• Meeting Coordination (Soft Skills)

Job Summary:

• Supports all aspects of TP Therapeutics’ clinical trials from initiation, planning, execution, maintenance, and close-out
• Collaborates/Interacts with CROs, vendors and clinical study sites
• Supports patient enrollment and data collection are completed following study timelines and objectives
• Reviews and assesses study documents required for site activation and investigational product release
• Schedule, set- up and minute study team and vendor meetings, as applicable
• Maintains metrics on results of study documentation reviews
• Supports in the review of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IxRS specification process and UAT
• Supports the planning of Investigator Meetings and/or Site and CRA trainings
• Manages the oversight of sample collection (i.e., tissue samples, lab samples, scans, PK samples)
• Ensures all relevant documents are uploaded into the Electronic Trial Master File (eTMF)
• Manages the exchange of TMF documents with external service providers, as applicable
• Performs periodic reviews and QC of the Trial Master File
• Provides applicable essential documents to Regulations for submission to the FDA
• Serves as a liaison and resource for investigational sites
• Participates in Site Initiation Visits and Co-monitoring Visits

Skills on Resume:

• Trial Management (Hard Skills)
• Vendor Collaboration (Soft Skills)
• Enrollment Support (Hard Skills)
• Document Review (Hard Skills)
• Meeting Coordination (Soft Skills)
• Metrics Maintenance (Hard Skills)
• Study Material Review (Hard Skills)
• Sample Oversight (Hard Skills)

Job Summary:

• Review and track clinical trial budgets, invoices, and related financial documentation activities (e.g. purchase orders)
• Assist with Financial reconciliation for clinical studies
• Review clinical study invoices against data entry and resolve any discrepancies with vendors
• Maintain communication and follow up with vendors on payment-related activities
• Complete contract request forms for the Legal department
• Assist with administrative support activities
• Assist with maintaining relevant tracking tools and other internal processes
• Classify documents according to the standardized TMF Reference Model.
• Enter required document metadata in an electronic TMF.
• Document and track trial document findings through resolution.
• Approve documents and confirm Inspection Readiness.
• Work with cross-functional teams to resolve trial document findings.

Skills on Resume:

• Budget Review (Hard Skills)
• Financial Reconciliation (Hard Skills)
• Invoice Management (Hard Skills)
• Vendor Communication (Soft Skills)
• Contract Assistance (Hard Skills)
• Administrative Support (Soft Skills)
• Tracking Tool Maintenance (Hard Skills)
• Document Classification (Hard Skills)

Job Summary:

• Provide general administrative support, scheduling and coordination of meetings, material and document distribution and/or shipments, coordination of correspondence, copying, electronic filing, etc.
• Draft meeting agendas and minutes
• Reviews and tracks monitoring reports from Clinical Research Organizations (CRO) to ensure safety, compliance and proper conduct throughout the trial as required by regulatory directives/guidelines and by sponsor and/or vendor SOPs
• Ensure clinical trial eTMFs are “inspection ready” at all times and eTMF documents are filed contemporaneously on time
• Assists with clinical invoices and timeline tracking
• Review and revise clinical study documents, manuals, and training material
• Circulate documents (i.e., protocols, informed consent forms, participant-facing material, vendor project plans, etc.) for review and approval
• Liaise with CRO to ensure completeness and quality of files within eTMF
• Supports COMs with study-specific tasks and provides weekly updates to the team
• Contribute to wider organizational goals and/or activities

Skills on Resume:

• Administrative Support (Soft Skills)
• Meeting Coordination (Soft Skills)
• Monitoring Report Review (Hard Skills)
• eTMF Management (Hard Skills)
• Invoice Tracking (Hard Skills)
• Document Revision (Hard Skills)
• Document Circulation (Hard Skills)
• CRO Liaison (Soft Skills)

Job Summary:

• Perform general clinical administrative functions such as clinical trial tracking and logistical support to the study execution teams (SET), including generation and distribution of SET meeting agendas and minutes
• Tracks and maintains study information and reports on study progress and enrollment
• Tracks and maintains study-related documents, including essential regulatory documents from clinical sites and any other supplementary documentation as appropriate (CVs, FDA 1572s, etc.)
• Independently maintain the study Trial Master File (TMF) following the relevant SOPs to ensure accuracy, completeness and adherence to the SOPs requirements
• Maintains and ensures that all documentation is in a state of audit-readiness
• Assist in the review and development of study-related documents and tools including site regulatory packages, study manuals, reference documents and instructions
• Assists with study closure activities such as ensuring final site payments, final reconciliation activities, filing, and archiving of all study documents
• Assist with the tracking of study budgets and vendor invoices to ensure timely approval and payment
• Assist with vendor management and associated logistics
• Assist with clinical data review
• Assist with informed consent development and review
• Assist in creating and implementing departmental procedures
• Perform all responsibilities following Standard Operating Procedures, established guidelines and work instructions, and appropriate industry and Good Clinical Practices standards

Skills on Resume:

• Administrative Support (Soft Skills)
• Study Tracking (Hard Skills)
• Document Management (Hard Skills)
• TMF Oversight (Hard Skills)
• Audit Readiness (Hard Skills)
• Document Review (Hard Skills)
• Study Closure (Hard Skills)
• Budget Tracking (Hard Skills)

Job Summary:

• Assists and provides support to the CTM and study team in the day-to-day operational management of assigned clinical trials
• Supports the Clinical Trial Manager in coordination, preparation, and documentation of internal and external meetings such as Kick-Off Meetings, Investigator Meetings, and vendor management meetings 
• Preparing agendas, minutes, and presentation materials, organizing meeting logistics and travel arrangements
• Assist with tracking purchase orders and invoices, site budgets, investigator payments, CTAs, etc
• Assists in tracking key site metrics and milestones such as Site Initiation Visits and site activation, subject recruitment and enrollment, critical study dosing days and assessments, scheduled Monitoring Visits and Close-Out Visits, etc
• Contribute to study level tracking by maintaining tools to track assignment and training of study team members, recruitment materials and compliance tools, laboratory kits, samples and study supplies, vendor portal access, etc
• Supports the CTM and study team through review of clinical documentation such as Informed Consent (ICF), Study Reference Binder, Study Management Plan, Monitoring Plan, Pharmacy Manual, Lab manual, study protocols, etc
• Assists in EDC and IXRS specification process and User Acceptance Training (UAT)
• Assists in clinical site oversite, data entry timeliness, review of monitoring trip reports and tracks resolution of all action items
• Assists in TMF management to ensure it is being maintained up-to-date and all essential documents are appropriately filed in the TMF
• Assist in the evaluation and selection of clinical study vendors including CRO, Data Management, IRT, Central labs, Imaging, etc
• Assists in the development and review of Standard Operating Procedures (SOPs)/processes for the clinical department

Skills on Resume:

• Operational Support (Soft Skills)
• Meeting Coordination (Soft Skills)
• Logistics Management (Hard Skills)
• Financial Tracking (Hard Skills)
• Site Metrics Tracking (Hard Skills)
• Study Level Tracking (Hard Skills)
• Document Review (Hard Skills)
• TMF Management (Hard Skills)

Job Summary:

• Coordinate, guide, and assist with all start-up activities in the US and globally before site activation
• Plan, coordinate, and arrange study communications with both internal and external attendees
• Set up, update, maintain and close Trial Master Files through the management of essential documents
• Communicate with CROs and investigator sites on a collection of regulatory documents, Institutional Review Board submissions, and follow-up visit reminders as directed by the Clinical Project Lead
• Create, populate, review, approve, distribute, and track study materials as assigned by the Clinical Project Lead
• Accountable for accurate organization and maintenance of filing systems and tracking departmental documentation through the use of SharePoint, electronic TMFs, etc.
• Create study materials, including newsletters, study templates, etc. under the direction of the Clinical Project Lead
• Actively participate and contribute ideas in the development of department initiatives and goals that will make a difference in the efficiency and effectiveness of clinical operations
• Regularly interact with high-level internal and external clients to coordinate the accomplishment of business needs
• Support efforts for and/or prepare a variety of correspondence and complex PowerPoint presentations
• Contribute to Site Informed Consent Form (ICF) localization and guidance in line with regulatory requirements
• Participate in the Clinical Trial Health Authority application and regulatory submission process
• Tracks metrics and study start-up timelines to identify trends and opportunities for improvement

Skills on Resume:

• Start-Up Coordination (Hard Skills)
• Study Communications (Soft Skills)
• TMF Management (Hard Skills)
• Regulatory Communication (Soft Skills)
• Material Tracking (Hard Skills)
• Filing Systems (Hard Skills)
• Study Material Creation (Hard Skills)
• Metric Tracking (Hard Skills)

Job Summary:

• Key support role in planning and executing clinical trials
• Assist with the development of project plans
• Assist with developments and maintain tracking and updating clinical project schedule
• Support the team with vendor identification, qualification, selection, and management throughout a clinical trial
• Create and maintain various study status trackers
• Coordinate and assemble clinical study materials
• Collate relevant clinical study information
• Develop and distribute meeting agendas, minutes, and monthly status reports
• Support the team in tracking subject recruitment and investigator site payments
• Assist the clinical team with site communication
• Assist the team with data review and data cleaning efforts
• Participate in internal meetings, client meetings and Investigator Meetings
• Support the preparation, collection, filling and archival of project and site-related essential documents for the Trial Master File

Skills on Resume:

• Trial Planning (Hard Skills)
• Project Development (Hard Skills)
• Schedule Tracking (Hard Skills)
• Vendor Management (Hard Skills)
• Status Tracking (Hard Skills)
• Material Coordination (Hard Skills)
• Data Review (Hard Skills)
• Document Archival (Hard Skills)

Job Summary:

• Support the clinical study teams in the overall management of studies, including planning, execution, and closeout of clinical trials
• Assist the Clinical Project Managers and the In-house Clinical Research Associates in site management activities
• Work closely with Clinical Project Managers to assist with the preparation of all external and internal documentation for assigned trials
• Assist in the creation of and distribution of study materials and communications to investigators, site personnel, CROs, and other external vendors
• Organize and prepare study files related to study tracking and reporting and submit them to the Trial Master File within established guidelines, maintain up-to-date documentation for all study sites
• Assist clinical team with IRB/EC submissions and informed consent reviews
• Support invoice and budget activities
• Assist in the development of SOPs and processes for the Clinical Operations department
• Manages multiple initiatives and shifts priorities within a small company environment
• Complete additional tasks as assigned and agreed upon

Skills on Resume:

• Study Management (Hard Skills)
• Site Management (Hard Skills)
• Documentation Preparation (Hard Skills)
• Material Distribution (Hard Skills)
• File Organization (Hard Skills)
• IRB Submissions (Hard Skills)
• Budget Support (Hard Skills)
• SOP Development (Hard Skills)

Job Summary:

• Support the clinical team regarding preparation of essential clinical trial documentation, ensuring distribution, tracking and filing of documents
• Assist with management and maintenance of eTMF or other program/study related files in accordance with GCP.
• Coordinate management and maintenance of study documents.
• Coordinate archiving of study documents as directed by operations trial leads.
• QC study documents
• Organize presentations for Investigator Meetings.
• Participate in the development of protocols and Case Report Forms as assigned.
• Participate in writing clinical trial reports as assigned.
• Support training of new users on eTMF, related SOPs, and systems access.
• As requested, arrange and participate in meetings to include preparation and distribution of agendas and meeting materials, and taking/distributing meeting minutes.
• Assist with the review, tracking and processing of payments/invoices related to investigators, consultants and service providers.
• Perform administrative duties in support of clinical trials
• Perform additional tasks as required to support Clinical Trial managers.

Skills on Resume:

• Documentation Preparation (Hard Skills)
• eTMF Management (Hard Skills)
• Document Coordination (Hard Skills)
• Document Archiving (Hard Skills)
• QC Documents (Hard Skills)
• Presentation Organization (Soft Skills)
• Protocol Development (Hard Skills)
• Payment Processing (Hard Skills)

Job Summary:

• Order and maintain clinical study supplies required for conduct of clinical trials
• Coordinate logistics for shipping material to clinical sites and vendors in support of clinical trials
• Support invoice and budget activities
• Support clinical site and vendor contract/agreement activities
• Assist with the auditing and reconciliation of all study related documents for trials
• Ensure timely completion of study tasks and update trial trackers on an on-going basis
• Follow established SOPs, ICH-GCP, and other applicable regulatory requirements across all tasks
• Proactively identify and resolve clinical study issues
• Support the clinical study team(s) in the overall management of studies, including planning, execution, and closeout of clinical trials
• Assist the Clinical Project Manager(s) and the Clinical Research Associate(s) in site management activities
• Work closely with Clinical Project Manager(s) to assist with preparation of all external and internal documentation for assigned trials
• Organize and prepare study files related to study tracking and reporting and submit them to the
• Trial Master File within established guidelines, maintain up-to-date documentation for all study sites
• Manages multiple initiatives and shifts priorities within fast-paced company environment

Skills on Resume:

• Supply Management (Hard Skills)
• Logistics Coordination (Hard Skills)
• Budget Support (Hard Skills)
• Contract Activities (Hard Skills)
• Document Auditing (Hard Skills)
• Task Tracking (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Issue Resolution (Soft Skills)

Job Summary:

• Support operational execution of global clinical trials, from start-up activities until study close-out
• Ensure operational support of clinical study teams including taking and distributing meeting minutes and follow up action items
• Interact with project team and external service providers including CRO(s), subcontractors, to assist with timely and efficient study start up activities including site feasibility management and site set up
• Management and tracking of site contracts, study insurances , EC or regulatory approvals and other trial related documentation
• Set-up, manage and maintain ICH GCP compliant Trial Master File and assist in review and audit of vendor Trial Master File to ensure compliance
• Is responsible for the electronic Trial Master File (eTMF Business Administrator)
• Develop and maintain appropriate tracking tools for trial related metrics
• Draft and/or provide input into department SOPs and procedures
• Support CST members in the coordination of contracts with sites/vendors/KOL.
• Be an active member of internal and external clinical study teams

Skills on Resume:

• Trial Execution (Hard Skills)
• Team Support (Soft Skills)
• Vendor Interaction (Soft Skills)
• Document Tracking (Hard Skills)
• TMF Management (Hard Skills)
• eTMF Administration (Hard Skills)
• Metric Tracking (Hard Skills)
• SOP Development (Hard Skills)

Job Summary:

• Collect, organize, and archive clinical trial master file documents, including clinical study site documents, email correspondence, training materials, and other study documents.
• Remote review of study data either via electronic data capture (EDC) system or tables, listings and figures (TLFs) developed by the data management team.
• Assist in study start up activities including but not limited to review of informed consents
• Review and development of study reference manuals, plans, and procedures, distribution, collection, and quality review of clinical study site regulatory packets.
• Work as a liaison with review boards and independent ethics committees, assisting clinical study sites and sponsors with their regulatory approval pathways.
• Provide general logistical support for clinical trial study teams, such as scheduling meetings, creating agendas, and taking minutes.
• Provide suggestions and contribute to implementation of process improvements in support of team, department, and company goals.
• Assist in organisation of Investigator’s meetings.
• Ensure that trial invoices are processed in a timely manner, maintain financial records for each study and invoice tracking list

Skills on Resume:

• Document Archiving (Hard Skills)
• Data Review (Hard Skills)
• Study Start-Up (Hard Skills)
• Manuals and Procedures (Hard Skills)
• Regulatory Liaison (Soft Skills)
• Logistical Support (Soft Skills)
• Process Improvement (Soft Skills)
• Invoice Management (Hard Skills)

Job Summary:

• Ensure study documentation, communication, training and data collection is aligned with study protocol adherence, and all applicable SOPs, regulations and guidelines
• Set-up and maintain the Trial Master File / electronic Trial Master File, and using applicable filesharing platforms (i.e., Z:drive, box.com) for clinical projects.
• Drafts and/or reviews study-related documents and templates including study protocols, informed consents, source document templates, study plans, study related logs, etc.
• Participate in study start-up (including Investigator Meeting), study maintenance and study closeout activities.
• Collect and review site regulatory documents for accuracy and completion (e.g., 1572, Financial Disclosure documents, CLIA waivers, etc.).
• Prepare, with oversight, essential documents package to support investigational product release for study and site approval.
• Create regulatory packages for IRB/IEC submission for study and site initial submission as well as applicable study and site continuity report submissions and close-out submissions.
• Assemble and distribute regulatory binders to clinical sites.

Skills on Resume:

• Protocol Adherence (Hard Skills)
• TMF Management (Hard Skills)
• Document Drafting (Hard Skills)
• Study Coordination (Hard Skills)
• Regulatory Review (Hard Skills)
• Document Preparation (Hard Skills)
• IRB/IEC Submissions (Hard Skills)
• Binder Assembly (Hard Skills)

Job Summary:

• Order and ship study-related supplies to clinical sites.
• Create Site Payments, obtain approval and submit to Accounting.
• Support Clinical Research Associates during monitoring visits to help ensure that any missing documents are filed within the eTMF and the site binder.
• Support project management activities including but not limited to drafting meeting agendas/minutes, drafting communication, and maintaining CTMS and the study tracker(s).
• Assist project managers in preparing study metric reports and collecting site status updates.
• Address Quality Control findings resulting from internal and external Trial Master File audits.
• Participate in Study Operations planning, Risk Assessment discussions and Pre-Study Meetings.
• Provide support to Clinical Operations for implementing process improvement actions, remaining current on all relative and applicable SOPs, and participating in departmental training sessions.
• Assist with audit preparations (i.e., Sponsor, IRB/IEC, FDA).

Skills on Resume:

• Supply Management (Hard Skills)
• Payment Processing (Hard Skills)
• Document Filing (Hard Skills)
• Project Support (Soft Skills)
• Metric Reporting (Hard Skills)
• Quality Control (Hard Skills)
• Operations Planning (Soft Skills)
• Audit Support (Hard Skills)

Job Summary:

• Compiles and tracks study metrics and other critical information using study trackers, databases, data forms, and reports
• Assists with the tracking and review of safety events
• Assists in coordinating site enrollment and reviewing site enrollment ready documents for initial supply release and subsequent supply requests
• Supports in reviewing regulatory documents and preparing ad hoc reports
• Assists in the development of critical study documents, including clinical protocols, ICFs, operational documents, study reference documents, study newsletters, site materials, and other study related documents
• Coordinates with vendors on patient recruitment material
• Provides vendor management support
• Assists in the financial tracking of clinical trials, including tracking site and vendor contracts and invoices

Skills on Resume:

• Metric Tracking (Hard Skills)
• Safety Event Review (Hard Skills)
• Enrollment Coordination (Hard Skills)
• Regulatory Review (Hard Skills)
• Document Development (Hard Skills)
• Vendor Coordination (Soft Skills)
• Vendor Management (Soft Skills)
• Financial Tracking (Hard Skills)

Job Summary:

• Provides support for overall site management to ensure appropriate study execution
• Assists in obtaining site confidentially agreement, feasibility and with other site recruitment activities
• Assists with completion, submission, and maintenance of site IRB/EC documents and reports 
• Ensures all Trial Master File related documents are properly obtained and filed in the electronic system and manages ongoing audits of the Trial Master File including completion of CAPAs, as applicable and reconciliation of Sponsor/CRO TMFs
• Compiles, tracks and sends study supplies to clinical sites, including drug supply related requests such as tracking drug accountability expiry lots, temperature excursion follow up and shipping requests
• Supports training of clinical sites to the protocol and other study-specific documents
• Assists in the coordination of investigator meetings or trainings (SIV, re-training, study coordinator meetings, ad-boards, etc.)
• Assists with clinical sample receipt, shipment, and tracking
• Assists with the coordination, preparation, and execution of clinical project meetings, safety meetings and any other study-specific committee meetings and associated minutes

Skills on Resume:

• Site Management (Hard Skills)
• Recruitment Support (Hard Skills)
• IRB/EC Documents (Hard Skills)
• TMF Management (Hard Skills)
• Supply Tracking (Hard Skills)
• Site Training (Soft Skills)
• Meeting Coordination (Soft Skills)
• Sample Tracking (Hard Skills)

Job Summary:

• Collect data by telephone or personal structured interviews within specified protocol windows
• Verify all work performed to ensure quality
• Track multiple sources for difficult to locate/contact subjects, including site coordinators, to maximize study participation during follow-up phases
• Participate in cross-training of interviewing studies to maximize workload and professional growth
• Identify and report to the Interviewing and Study Coordinators data quality/quantity problems from review and analysis of standard computer reports/logs/protocol timelines
• Review prepared standard scheduler and query reports with accuracy and according to protocol timelines
• Monitor and summarize status of all data collection activities weekly from computer reports and logs and report to the Interviewing Coordinator and study team during weekly meetings
• Monitor and summarize computer-based reports of patients enrolled and forms received and report to data analyst and study coordinator
• Maintain computer database entry of telephone calls and conversations
• Assist in training new personnel

Skills on Resume:

• Data Collection (Hard Skills)
• Quality Verification (Hard Skills)
• Subject Tracking (Soft Skills)
• Cross-Training (Soft Skills)
• Problem Reporting (Hard Skills)
• Report Review (Hard Skills)
• Activity Monitoring (Hard Skills)
• Training Support (Soft Skills)

Job Summary:

• Interacts directly with Clinical Affairs staff (e.g., CRAs, CTAs), site staff, vendors in the U.S. (or worldwide) to provide management of clinical trials.
• May work under the direction of a more senior Clinical Trial Manager.
• Manages key performance indicators and study metrics and prepares correspondence, spreadsheets and presentations to report progress on clinical operations tasks or benchmarks.
• Develops Clinical operations processes and procedures, including the Clinical Monitoring Plan and study specific CRA training materials. 
• Ensures CRA compliance to the CMP, conducts CRA training, and maintains documentation of training.
• Communicates monitoring and site management updates and/or issues to team.
• Writes or contributes to the development of clinical protocols, amendments, clinical study reports, informed consent forms, case report forms (CRFs), instructions for use, and any other clinical research related documents.
• Assumes overall responsibility for site agreements, budget negotiations, regulatory approvals through Institutional Review Boards /Ethics Committees, development of recruitment strategies, and provision of clinical study materials.
• Convenes and leads inter and interdepartmental clinical research meetings, ensuring that colleagues are updated on all relevant issues.
• Ensures GCP compliance and smooth execution of assigned clinical research studies by overseeing all aspects of the research project, including site start-up activities, clinical site management, ethical review board information, management of the study Trial Master File and by closely managing the financials of the project.

Skills on Resume:

• Trial Management (Hard Skills)
• KPI Tracking (Hard Skills)
• Process Development (Hard Skills)
• CRA Training (Hard Skills)
• Monitoring Updates (Soft Skills)
• Document Development (Hard Skills)
• Site Agreements (Hard Skills)
• GCP Compliance (Hard Skills)

Job Summary:

• Develops clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables. 
• Reviews monitoring visit reports and assures adherence to study timelines for report submission and finalization.
• Oversees the clinical study data collection and curation process by developing monitoring strategies and data-management strategies that govern clinical data integrity.
• Promotes operational efficiency, teamwork and high morale among CRAs and CTAs.
• Proactively prevents and identifies issues related to the clinical project, including study processes, monitoring or site issues.
• Works with Senior Management to identify, hire and oversee CROs, vendors and/or study suppliers.
• Works closely with department management for resourcing issues and escalates pertinent CRA performance and site compliance issues
• Direct or line management of CRAs and CTAs.

Skills on Resume:

• Monitoring Strategy (Hard Skills)
• Report Review (Hard Skills)
• Data Management (Hard Skills)
• Team Leadership (Soft Skills)
• Issue Prevention (Soft Skills)
• Vendor Management (Hard Skills)
• Resource Coordination (Soft Skills)
• Staff Management (Soft Skills)

Job Summary:

• Assist with customization of Confidential Disclosure Agreement, clinical site contracts & budgets
• Track Vendors and/or internal Study Management Team performance against deliverables, contracts, and timelines
• Assist project teams with trial registration by drafting the Clinical Trial
• gov and ANZCTR registration submissions
• Appropriately escalates issues in a timely manner and ensures resolution
• Support the Director of Clinical Operations or delegate in the development and maintenance of clinical SOPs & trial process
• Build a positive culture within clinical operations and cross-functionally
• Approve documents and confirm Inspection Readiness.
• Work with cross-functional teams to resolve trial document findings.

Skills on Resume:

• Contract Customization (Hard Skills)
• Vendor Tracking (Hard Skills)
• Trial Registration (Hard Skills)
• Issue Escalation (Soft Skills)
• SOP Development (Hard Skills)
• Culture Building (Soft Skills)
• Inspection Readiness (Hard Skills)
• Document Resolution (Hard Skills)

Job Summary:

• Perform general clinical administrative functions such as clinical trial tracking and logistical support to the study execution teams (SET), including generation and distribution of SET meeting agendas and minutes
• Tracks and maintains study information and reports on study progress and enrollment
• Tracks and maintains study-related documents, including essential regulatory documents from clinical sites and any other supplementary documentation as appropriate (CVs, FDA 1572s, etc.)
• Independently maintain the study Trial Master File (TMF) in accordance with the relevant SOPs to ensure accuracy, completeness and adherence to the SOPs requirements
• Maintains and ensures that all documentation is in a state of audit-readiness
• Assist in the review and development of study-related documents and tools including but not limited to site regulatory packages, study manuals, reference documents and instructions
• Assists with study closure activities such as ensuring final sites payments, final reconciliation activities, filing, and archiving of all study documents
• May assist with the tracking of study budgets and vendor invoices to ensure timely approval and payment
• Assist with vendor management and associated logistics
• May assist with clinical data review
• May assist with informed consent development and review
• May assist in creating and implementing departmental procedures
• Perform all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, and appropriate industry and Good Clinical Practices standards
• Contribute to wider organizational goals and/or activities as assigned

Skills on Resume:

• Administrative Support (Soft Skills)
• Progress Tracking (Hard Skills)
• Document Maintenance (Hard Skills)
• TMF Management (Hard Skills)
• Audit Readiness (Hard Skills)
• Document Development (Hard Skills)
• Study Closure (Hard Skills)
• Vendor Management (Soft Skills)

Job Summary:

• Assists and provides support to the CTM and study team in the day-to-day operational management of assigned clinical trials
• Supports the Clinical Trial Manager in coordination, preparation, and documentation of internal and external meetings such as Kick-Off Meetings, Investigator Meetings, and vendor management meetings by preparing agendas, minutes, and presentation materials, organizing meeting logistics and travel arrangements 
• Assist with tracking of purchase orders and invoices, site budgets, investigator payments, CTAs, etc
• Assists in tracking key site metrics and milestones such as Site Initiation Visits and site activation, subject recruitment and enrollment, critical study dosing days and assessments, scheduled Monitoring Visits and Close-Out Visits etc
• Contribute to study level tracking by maintaining tools to track assignment and training of study team members, recruitment materials and compliance tools, laboratory kits, samples and study supplies, vendor portal access, etc
• Supports the CTM and study team through review of clinical documentation such as Informed Consent (ICF), Study Reference Binder, Study Management Plan, Monitoring plan, Pharmacy manual, Lab manual, study protocols etc
• Assists in EDC and IXRS specification process and User Acceptance Training (UAT)
• Assists in clinical site oversite, data entry timeliness, review of monitoring trip reports and tracks resolution of all action items
• Assists in TMF management to ensure it is being maintained up-to-date and all essential documents are appropriately filed in the TMF
• Assist in evaluation and selection of clinical study vendors including CRO, Data Management, IRT, Central labs, Imaging, etc
• Assists in the development and review of Standard Operating Procedures (SOPs)/processes for the clinical department

Skills on Resume:

• Operational Support (Soft Skills)
• Meeting Coordination (Soft Skills)
• Financial Tracking (Hard Skills)
• Metric Tracking (Hard Skills)
• Tool Maintenance (Hard Skills)
• Document Review (Hard Skills)
• UAT Support (Hard Skills)
• Site Oversight (Hard Skills)