Job Summary: 

• Assist CTO research team members in screening, recruiting and enrolling patients into clinical trials.
• Coordinate patient visits in a clinic. 
• Organize study participant charts and files, and distribute them to the appropriate location
• Collect required data from study participants, and enter them into clinical research forms and computerized databases
• Extract data from electronic medical records systems such as Epic
• Collect samples, process and ship to laboratories and maintain a supply inventory.
• Generate letters to be sent to study participants
• Contact patients after initial contact to obtain additional information
• Provide general clerical support to study teams
• Order and maintain a log of stipend checks and/or gift certificates to be distributed to study participants
• Compile outreach packets, recruitment and specimen collection kits
• Demonstrate understanding of IRB, GCP and HIPAA practices, responsible for maintaining training and credentials.
• Identifies and communicates important protocol and data management issues or problem areas to the supervisor

Skills on Resume: 

• Patient Recruitment and Enrollment (Hard Skills)
• Coordination of Clinic Visits (Hard Skills)
• Data Management (Hard Skills)
• Data Collection and Entry (Hard Skills)
• Sample Handling and Inventory Management (Hard Skills)
• Communication and Documentation (Soft Skills)
• Financial Administration (Hard Skills)
• Regulatory and Compliance Knowledge (Hard Skills)

Job Summary: 

• Provide general support to the Clinical Affairs and Regulatory Affairs Group by assisting with the execution and maintenance of clinical studying and preparation of regulatory documents.
• Establish and update various databases for clinical tracking.
• Create, update, track, and maintain study-specific trial management files.
• Order, ship, and maintain clinical study supplies and in-house clinical inventory.
• Ship and track investigational materials to study sites.
• Prepare study binders for the clinical sites and coordinate technical support for field monitors.
• Assist the Clinical team with administrative activities (payments to investigators, travel planning, photocopying, making labels, etc.)
• Assist with the preparation copying, and printing of regulatory submission documents.
• Assist with coordinating and conducting testing in support of regulatory submissions.
• Assist in planning team meetings and maintaining in-house Clinical biorepository.
• Help develop, prepare, and submit grants, papers/abstracts, manuscripts, and edited presentations
• Tracks orders and informs lab personnel of the status of the order
• Organizes research laboratory work environment in conjunction with lab personnel

Skills on Resume: 

• Clinical Documentation Management (Hard Skills)
• Database Management (Hard Skills)
• Supply Chain Coordination (Hard Skills)
• Administrative Support (Soft Skills)
• Technical Support Coordination (Soft Skills)
• Meeting and Event Planning (Soft Skills)
• Grant and Manuscript Preparation (Hard Skills)
• Laboratory Organization (Hard Skills)

Job Summary: 

• Assist Core leadership with the coordination and administration of the research projects.
• Work with other investigators/coordinators to develop and communicate study processes before each study implementation
• Collect information through interview visits, telephone and/or written communication with patients/families
• Establish research reliability on psychological measures listed above and administer assessments to research participants during study visits
• Organize, and maintain study documents and utilize word processing and hospital/study databases for data entry/extraction and report generation
• Schedule meetings and prepare required meeting documents
• Schedule research participants for study visits.
• Act as a resource to participants, referring questions to the appropriate researcher
• Coordinate follow-up study visits and order supplies or equipment used in the studies
• Work directly with the hospital and research laboratories to ensure correct testing/processing and send out instructions specific to the study
• Conduct statistical analysis using SPSS or similar and is familiar with databases
• Organize and complete special projects

Skills on Resume: 

• Research Coordination (Hard Skills)
• Effective Communication (Soft Skills)
• Assessment Administration (Hard Skills)
• Data Management (Hard Skills)
• Scheduling and Organization (Hard Skills)
• Participant Support (Soft Skills)
• Resource Coordination (Hard Skills)
• Statistical Analysis and Database Management (Hard Skills)

Job Summary: 

• Assists with clinical research studies as per study guidelines and protocols.
• Recruits, screens, and tracks study participants.
• Administers assessments, performs interviews and administers tasks.
• Assists with neuroimaging scans and other physiological measurements.
• Develops, organizes, and/or maintains study databases.
• Responsible for data validation and quality control, data processing, and some data analysis.
• Monitors and sets up any needed equipment.
• In conjunction with the Principal Investigator, implements Institutional Review Board applications and maintains study documentation.
• Maintains inventory and orders supplies and assists with the preparation of new grant applications.
• Assists with the preparation of presentations and written manuscripts for publication.
• Performs literature searches and train and orients students in the laboratory.
• Assist in maintaining study databases/files, scheduling study appointments, developing protocol manuals, and participating in field visits

Skills on Resume: 

• Clinical Research Assistance (Hard Skills)
• Participant Recruitment and Screening (Hard Skills)
• Assessment Administration (Hard Skills)
• Neuroimaging and Physiological Measurements (Hard Skills)
• Database Management (Hard Skills)
• Data Validation and Analysis (Hard Skills)
• Institutional Review Board (IRB) Compliance (Hard Skills)
• Grant Preparation and Documentation (Hard Skills)

Job Summary: 

• Recruit, consent, enroll, and track study participants
• Conduct structured mental health diagnostic interviews and interviews assessing prescription medication and drug abuse and misuse
• Use specialized computer programs to assist in participant identification, data collection, and tracking such as DatStat, RedCap, and Smartsheet, electronic medical records, etc.
• Identify, appropriately respond to, triage, report and follow up on participant-related concerns, including detailed documentation of critical incidents (e.g., reports of suicide ideation/intent)
• Participate in all study-related training sessions, which may include travel.
• Organize meetings, conference calls, arrange travel and submit purchase requests and track progress
• Participate in team meetings, maintain project tasks in Smartsheet and take meeting minutes
• Prepare IRB materials and the development and revisions of protocols, maintain informed consent and HIPAA forms, prepare annual reports etc.
• Maintain site-specific Standard Operating Procedures and Policies
• Contribute to the dissemination of study results
• Assist the research team with the publication of manuscripts and presentations
• Assist in the preparation of grant applications, which may include drafting assigned sections

Skills on Resume: 

• Participant Recruitment and Management (Hard Skills)
• Specialized Software Proficiency (Hard Skills)
• Crisis Management and Documentation (Soft Skills)
• Training and Travel Coordination (Soft Skills)
• Project Management and Meeting Facilitation (Hard Skills)
• Regulatory and Compliance Documentation (Hard Skills)
• SOP and Policy Maintenance (Hard Skills)
• Research Dissemination and Grant Preparation (Hard Skills)

Job Summary: 

• Review medical records and assist with data extraction, entry, and submission
• Assist with scheduling and conducting monitoring visits and query resolution
• Request medical records, and images and respond to inquiries from study participants
• Assist with bio-specimen processing and tissue requests
• Administer and supervise training for undergraduate students and additional research assistants
• Attend coordinator’s training and rounds and schedule patients for research appointments
• Establish and maintain database files and progress reports for studies, projects, and programs
• Collect required data from study coordinators and research nurses.
• Code and enter clinical research forms into a computerized database.
• Coordinate and support protocol adherence during the enrollment period in the ED and on the floor
• Compose letters to study participants.

Skills on Resume: 

• Medical Records Management (Hard Skills)
• Monitoring and Query Resolution (Hard Skills)
• Patient and Participant Communication (Soft Skills)
• Bio-specimen Processing (Hard Skills)
• Training and Supervision (Soft Skills)
• Database Management (Hard Skills)
• Data Collection and Entry (Hard Skills)
• Protocol Coordination (Hard Skills)

Job Summary: 

• Represents data management and study coordination when applicable at all internal and external meetings
• Provides data management and study status updates
• Performs additional data cleaning and reconciliation before data capture and monitor visits
• Utilizes the electronic health records system for data extraction and to screen patient charts for study eligibility.
• Schedules and oversees Clinical Research Associate’s monitoring visits.
• Oversees the day-to-day activities of study implementation of observational and registry studies.
• Recruits and consents subjects in compliance with human subjects protections and GCP.
• Maintains all study-related documents per protocol and assists in regulatory activities
• Completes or facilitates the completion of sponsor-initiated correspondence and data queries.
• Participates in internal and external audits
• Provides support to and takes work direction from the Study Coordinators, and Principal Investigators, and performs other duties
• Recognizes, exemplifies and adheres to Fairview’s values, which center on commitment to Dignity, Integrity, Service and Compassion.
• Provide relevant research information to support nurses and investigators.

Skills on Resume: 

• Data Management and Coordination (Hard Skills)
• Data Cleaning and Reconciliation (Hard Skills)
• Electronic Health Records (EHR) Utilization (Hard Skills)
• Clinical Research Associate Oversight (Hard Skills)
• Study Implementation Management (Hard Skills)
• Subject Recruitment and Consent (Hard Skills)
• Regulatory Compliance and Document Maintenance (Hard Skills)
• Audit Participation and Support (Hard Skills)

Job Summary: 

• Prepare, coordinate collection of, and process lab kits by the study protocol and lab manual, ensuring compliance with all research-related regulations may include coordination with infectious disease inpatient wards
• Organize, prepare, process and ship biological specimens including but not limited to human blood, urine, sputum, feces and/or tissue ensuring compliance with IATA, local, and federal shipping regulations and guidelines
• Utilize and maintain established procedures and systems (i.e., Clinical Trials Management System) for research coordination and accurate and timely lab kit management, specimen collection, and pathology/imaging requests
• Contribute to improvements in research information systems
• Answer queries submit time estimates, and other FDA/IRB- and sponsor-mandated documents
• Submit necessary IRB or FDA paperwork per institution and/or federal regulations
• Ensure quality assurance controls for accuracy, completeness, and confidentiality of research data
• Provide support to individual physician investigators and other Clinical Research team members to ensure compliance with protocol and lab manual requirements
• Ensure confidentiality of all information related to patients, medical staff, and other information, complying with federal HIPAA regulations
• Support and contribute to effective safety and risk management efforts by adhering to established policies and procedures
• Maintain a safe environment, promote accident prevention, and identify and report potential liabilities
• Serve as a resource liaison for investigators and other researchers involved in the day-to-day management of patients on clinical trials
• Demonstrate positive interactions with the public and positive interpersonal relations in dealing with fellow employees, supervisors, and other department employees, so that productivity and positive employee relations are maximized

Skills on Resume: 

• Lab Kit Management and Coordination (Hard Skills)
• Specimen Handling and Shipping (Hard Skills)
• Clinical Trials Management Systems (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Quality Assurance (Hard Skills)
• Support and Collaboration (Soft Skills)
• Confidentiality and HIPAA Compliance (Hard Skills)
• Safety and Risk Management (Hard Skills)

Job Summary: 

• Under the direction of the study coordinator, research manager, and/ or principal investigators
• Conduct research activities including administering surveys, recruiting, enrolling and following up with study participants
• Organize study participant charts, and files, and maintain up-to-date files.
• Maintain accurate and timely research records while maintaining patient confidentiality, according to the principles of Good Clinical Practice (GCP) and regulatory compliance.
• Collect samples from patients and process and transport samples
• Verify the accuracy of distributed incentives.
• Establish and promote positive working relationships within the department, throughout the hospital and between other institutions involved in cancer research
• Report to work as scheduled and on time per department policy
• Retain availability for research lab kit collections and processing after standard clinic hours and on weekends
• Retain availability for traveling to satellite sites for research-related needs
• Enroll eligible patients in trials based on the protocol
• Set appointments for potential research subjects to come in for screening

Skills on Resume: 

• Research Administration (Hard Skills)
• Organizational Skills (Hard Skills)
• Record Keeping (Hard Skills)
• Sample Collection and Processing (Hard Skills)
• Incentive Verification (Hard Skills)
• Relationship Building (Soft Skills)
• Flexibility and Availability (Soft Skills)
• Patient Enrollment (Hard Skills)

Job Summary: 

• Manage center-related aspects of multi-center clinical trials including coordination of regulatory documents.
• Manage study site certifications, study data and study image receipt, and manage the processing of the images through the grading and reporting process
• Responsible for knowing regulatory requirements specific to Clinical Trials
• Responsible for project management/process improvement supporting the Director
• Create study-specific site manuals and project plans
• Ensure that all regulatory compliances are met, appropriate IRB submissions are maintained, and all data collection is accurate
• Maintain study-specific regulatory binders
• Facilitate inventory, readings, data transfers and archiving of study materials
• Maintain inventory and documentation related to receipt of study/certification images and materials
• Conduct proper informed consent for eligible patients
• Collaborate with the study staff to ensure study screening enrollment needs are being met
• Once the trial begins start the process over again on a new trial
• Assist in the preparation of grant proposals

Skills on Resume: 

• Regulatory Compliance Management (Hard Skills)
• Project Management (Hard Skills)
• Clinical Trial Coordination (Hard Skills)
• Document and Inventory Management (Hard Skills)
• Study-Specific Documentation (Hard Skills)
• Informed Consent (Hard Skills)
• Collaboration and Coordination (Soft Skills)
• Grant Proposal Preparation (Hard Skills)

Job Summary: 

• Schedules research participants for all trial-related activities required by the research protocol.
• Obtains, stores and ships biological specimens according to research protocol.
• Draw blood and collect additional specimens
• Collects data via in-person and/or telephone interviews with clinic patients, participants, and caregivers
• Administers and scores an assortment of neuropsychological, lifestyle and physical function tests with patients, participants, and caregivers.
• Promptly enters data into electronic forms and/or web-based applications.
• Check data for completeness and accuracy
• Utilize internal web-based systems to schedule, track, and update participant and patient information.
• Maintain participant and patient charts including editing for completeness and accuracy
• Review patient charts to determine eligibility status according to research protocol
• Applies a thorough knowledge of the research protocols to serve as a resource person to the clinicians and study coordinators
• Assists clinicians and study coordinators to ensure research protocol compliance and to maximize overall participant satisfaction.

Skills on Resume: 

• Participant Scheduling and Coordination (Hard Skills)
• Specimen Handling and Shipping (Hard Skills)
• Data Collection and Management (Hard Skills)
• Test Administration (Hard Skills)
• Data Quality Assurance (Hard Skills)
• Chart Maintenance and Review (Hard Skills)
• Protocol Compliance and Resource Support (Hard Skills)
• Participant Satisfaction Enhancement (Soft Skills)

Job Summary: 

• Support Government Directors & Principal Investigators (PI's) in the planning, programming and execution of clinical research projects and protocols, and associated activities.
• Supports Government directors and PIs in the planning, programming, and execution of clinical research projects and protocols and associated activities
• Maintain records for contacting study participants by protocols and schedules, observe study participants and provide follow-up documentation to the PI
• Coordinate one or more simultaneous projects for the PI/director, including working with the investigator on experimental design
• Provides instruction on various research laboratory techniques and study participant contact procedures
• Organize research information and manage reporting and data collection
• Monitor research study budget and be responsible for Data collection, entry, and management
• Assist in support of clinical research studies and assist with the implementation and coordination of studies
• Participates in the recruitment of study participants
• Performs behavioral or diagnostic testing and assists with the collection maintenance & reporting of clinical research data.
• Monitoring and regulatory compliance of various studies

Skills on Resume: 

• Clinical Research Coordination (Hard Skills)
• Participant Management (Soft Skills)
• Research Data Management (Hard Skills)
• Budget Monitoring (Hard Skills)
• Recruitment and Testing (Hard Skills)
• Instruction and Training (Soft Skills)
• Regulatory Compliance (Hard Skills)
• Project Support and Coordination (Soft Skills)

Job Summary: 

• Conduct assigned clinical study activities by applicable regulations, GCP, and ADD policies and procedures.
• Manage clinical study master files to ensure documents maintained in the file are appropriate and the content of those documents is accurate, complete and consistent with procedures and regulatory requirements.
• Manage and track Investigational Product supplies for study centers
• Receives and prepares requests, ships and returns Investigational Product supplies
• Prepare, ship and manage inventory of study-related supplies
• Prepare and submit departmental invoices and POs for payment
• Manage the translation and tracking of translations for appropriate study documents.
• Preparation activities required for regulatory and QA audits.
• Provide Support for new and innovative processes and technologies to increase quality, productivity, and efficiency.
• Support scheduling and tracking of internal study monitoring visits.
• Conduct monitoring visits for internal clinical studies.
• Discrete and professional patient interaction and data collection and data management.
• Coordination of clinical research with biomarker studies

Skills on Resume: 

• Regulatory Compliance and GCP Adherence (Hard Skills)
• Clinical Study Master File Management (Hard Skills)
• Investigational Product Supply Management (Hard Skills)
• Inventory and Supply Management (Hard Skills)
• Document Translation and Management (Hard Skills)
• Audit Preparation (Hard Skills)
• Process Improvement and Innovation (Soft Skills)
• Clinical Study Monitoring and Coordination (Hard Skills)

Job Summary: 

• Assists with the completion of all study documentation forms, including case report forms and other study-specific documents.
• Maintains complete and accurate regulatory documentation and subject data.
• Ensures assigned studies are conducted by the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), Good Clinical Practices (GCP), and institutional guidelines.
• Maintains knowledge and understanding of assigned protocols, including all protocol requirements for patient visits.
• With specific training and approval from the Director, of Clinical Research Operations, assists in obtaining informed consent for non-interventional studies.
• Reviews and responds to all regulatory requirements for all study protocols
• Assists with all required forms/documents for initial study with IRB.
• Schedules medical procedures/tests necessary for research, including blood draws and imaging studies.
• Supports the investigator in the recruitment and selection of study participants.
• Assisting with disseminating findings through presentations and manuscripts
• Conduct literature reviews and gather background information on specific policy changes
• Manage IRB applications, protocols, and continuing reviews

Skills on Resume: 

• Regulatory Compliance Management (Hard Skills)
• Clinical Documentation (Hard Skills)
• Protocol Knowledge (Hard Skills)
• Informed Consent Assistance (Hard Skills)
• Study Participant Recruitment (Soft Skills)
• Scheduling and Coordination (Soft Skills)
• Research Dissemination (Hard Skills)
• IRB Management (Hard Skills)

Job Summary: 

• Following established procedures & guidelines and complying with applicable regulations
• Assists the study team in preparing the environment for conducting research activities as per protocol.
• Performs data transcription from health records or other sources, study protocol and authorized access
• Redacting sources, scanning, filing and organizing source
• Assists in the preparation and close-out of submissions to the Research Ethics Board
• Assists Study coordinators by obtaining signatures, maintaining study trackers, collecting CVs, Medical Licenses & Training documents and maintaining Regulatory binders
• Helps with Study start-up like completing 1572, Financial Disclosure forms, QIU and help with close-out activities, etc
• Performs administrative functions such as room bookings, supply ordering, maintaining timesheets, lab licenses, administrative binders, etc to support the management of the department.
• Assists with the maintenance & modification of electronic & paper information filing/retrieval methods, systems and/or formats along with archiving study documents
• Obtaining and combining novel data sources
• Extracting, cleaning, and analyzing data (e.g., medical claims, surveys, clinical outcomes)
• Evaluating the impact of health policies on healthcare access, use, quality, and spending
• Active participation in research meetings, be responsible for participant recruitment and follow-up survey assessments

Skills on Resume: 

• Regulatory Compliance and Procedure Adherence (Hard Skills)
• Research Preparation and Protocol Compliance (Hard Skills)
• Data Management and Transcription (Hard Skills)
• Ethics Board Submissions and Close-Out (Hard Skills)
• Study Coordination Support (Soft Skills)
• Administrative and Operational Support (Soft Skills)
• Data Analysis and Evaluation (Hard Skills)
• Participant Recruitment and Research Meetings (Soft Skills)

Job Summary: 

• Writing of Post Market Clinical Follow Up plans to meet the MDCG 2020-7 guidelines
• Work with the Clinical Specialists to ensure the CRFs are fit for purpose
• Liaising with the translation agency to ensure PMCF plans and CRFs are ready translated into appropriate languages
• Working with ConvaTec colleagues to identify and brief HCPs on PMCF activities
• Setting up PMCF studies and collating and processing of PMCF CRFs.
• Liaising with HCPs to ensure the PMCF activities are conducted on time and within budget
• Liaising with the data management company to ensure that the data are processed accurately and on time
• On time and in full reporting of Post Market Clinical Follow Up Studies
• Reporting of adverse events and device malfunctions as per ConvaTec’s procedures
• Working with the Clinical Project Manager on the implementation of EDC for use in PMCF studies
• Conducting online searches for clinical information, competitor monitoring, and current awareness
• Participant recruitment, scheduling, and testing
• Research and regulatory protocol management

Skills on Resume: 

• Regulatory Compliance and Documentation (Hard Skills)
• Clinical Data Management (Hard Skills)
• Translation and Localization Coordination (Hard Skills)
• Healthcare Professional (HCP) Liaison (Soft Skills)
• Project Management (Hard Skills)
• Adverse Event and Device Malfunction Reporting (Hard Skills)
• Electronic Data Capture (EDC) Implementation (Hard Skills)
• Research and Market Monitoring (Hard Skills)

Job Summary: 

• Communication with all elements of a multi-level research network, interacting with sponsoring agencies and compliance and regulatory groups such as the Institutional Review Board (IRB), and other sponsor monitors
• Study coordination and operation, including scheduling of various exams and assessments for both in-person and remote participants
• Organizing and archiving clinical trial master file documents, including clinical study site documents, email correspondence, training materials and other study documents
• Administering clinical trials according to good clinical practices (GCPs) and standard operating procedures (SOPs)
• Ensuring all Non-Disclosure Agreements (NDAs) are in place with relevant external parties
• Acting as key contact between ConvaTec and PMCF study site
• Provide general logistical support for PMCF studies and clinical trials such as the provision and shipment of products to support both PMCF and clinical studies
• Maintenance/Monitoring of the Clinical stockroom
• Coordination of global clinical activities
• Providing support for the development of publications and posters.
• Completing submissions of articles to journals and congress meetings
• Ordering and purchasing of publications to support Clinical Evaluation Report (CER) writing

Skills on Resume: 

• Advanced Communication and Coordination (Soft Skills)
• Clinical Trial Coordination (Hard Skills)
• Document Management (Hard Skills)
• Compliance with GCPs and SOPs (Hard Skills)
• NDA Management (Hard Skills)
• Logistical Support (Hard Skills)
• Global Clinical Coordination (Hard Skills)
• Publication and Documentation Support (Hard Skills)

Job Summary: 

• Coordinates facilitates, and maintains all Cancer Center's clinical trials administrative functions that facilitate adherence to the requirements set forth by SHS IRRC and all applicable Federal and State regulatory agencies.
• Responsible for orientation and training of onboarding CRA's
• Ensures that Cancer Center clinical trial studies are compliant with State and Federal regulatory requirements for research involving human subjects.
• Responsible for accurate interpretation of regulations, policies, and procedures for the clinical trial nurse and investigators
• Responsible for overseeing the CRA team's analysis of protocol information for proposed clinical trial studies, including evaluation of resource/expenditure needs
• Review of regulatory requirements, assessment of patient eligibility for proposed clinical trials, and consultation with physicians to verify patient's appropriateness for entry.
• Responsible for the performance of the randomization process
• Responsible for the timely submission of the clinical trial application, approved protocol, amendments, notices, suspensions, adverse event reports, study reviews, study closure notices, and termination documentation to the IRB and all applicable regulatory agencies for review, approval, and re-approval
• Responsible for oversight of the CRA team's function related to the timely submission of IRB applications
• Responsible for maintaining an administrative file for protocol documents, trial sponsor correspondence, IRB correspondence.
• Maintains and monitors patient case records for accuracy, quality of data, and compliance with protocol guidelines
• Responsible for and oversight activities related to compiling and maintaining clinical trial findings, generating reports, and utilizing clinical trial-appropriate checklists and templates and software systems to record data.
• Responsible for chart review, timely data collection and submission for audits (i.e. CCOP)

Skills on Resume: 

• Clinical Trial Coordination (Hard Skills)
• Regulatory Compliance Management (Hard Skills)
• Training and Orientation (Soft Skills)
• Protocol and Resource Evaluation (Hard Skills)
• Patient Eligibility Assessment (Hard Skills)
• Documentation and Submission Oversight (Hard Skills)
• Data Accuracy and Quality Monitoring (Hard Skills)
• Audit and Report Generation (Hard Skills)

Job Summary: 

• Responsible for specimen processing, storage, and shipment
• In cooperation with the principal investigator, identify and record standards of care versus trial-related requirements.
• Coordinate and maintain trial-related activities.
• Responsible for oversight of the CRA team's roles and responsibilities surrounding the weekly trial review meetings.
• Provides internal correspondence and education to staff regarding protocol specifics and serves as a resource regarding clinical trial questions and available trials.
• Responsible for monthly statistical reports on current and available trials including information on active protocols, number of patients enrolled, adverse events, and IRB status
• Responsible for scheduling study monitor's site visits, arranging meetings with the PI and pharmacist to discuss the study
• Provides the monitor with an update on any study-related issues and ensures that the appropriate patient records will be available for review at the time of the monitoring visit
• Oversees the CRA team's role of ensuring that all data queries received to date have been resolved to the extent possible
• After monitoring visits, meets with the study monitor to discuss any issues related to adherence to the protocol, review of regulatory files, verification of data in the CRFS with source documentation
• Assist the pharmacist with any questions regarding study drug storage, dispensing and accountability requirements for data storage
• Ensures that issues identified for resolution or follow-up at the monitoring visit are addressed
• Report results back to PI and research staff

Skills on Resume: 

• Specimen Management (Hard Skills)
• Protocol Compliance and Coordination (Hard Skills)
• Team Oversight and Coordination (Soft Skills)
• Internal Correspondence and Education (Soft Skills)
• Statistical Reporting (Hard Skills)
• Study Monitoring and Scheduling (Hard Skills)
• Data Query Resolution (Hard Skills)
• Regulatory Compliance and Issue Resolution (Hard Skills)

Job Summary: 

• Establishing and updating various databases for clinical tracking
• Creating, updating, tracking, and maintaining study-specific trial management files
• Ordering, shipping, and maintenance of clinical study supplies and in-house clinical inventory
• Shipping and tracking of investigational materials to study sites
• Preparation of study binders for the clinical sites 
• Coordinating technical support for field monitors and assisting with specimen preparation and logistics
• Assisting the clinical team with administrative activities (e.g. payments to investigators, travel planning, etc)
• Assisting Clinical Manager with monitoring tasks (e.g. review of Case Report Forms, Study files, device accountability, and database entry)
• Assisting with preparing, copying, and printing regulatory submission documents
• Assisting with coordinating and conducting testing in support of regulatory submissions
• Be responsible for feasibility and research coordination for all clinical trials across all specialties.
• Support trial coordinators in cardiology, with the opportunity to assist in other care areas.

Skills on Resume: 

• Database Management (Hard Skills)
• Trial Management Documentation (Hard Skills)
• Inventory and Supply Chain Management (Hard Skills)
• Technical Support Coordination (Hard Skills)
• Administrative Support (Soft Skills)
• Monitoring and Data Review (Hard Skills)
• Regulatory Submission Support (Hard Skills)
• Feasibility and Research Coordination (Hard Skills)