Job Summary:

• Assist with, support, back-up and/or perform assigned functions and escalated issues or problems to ensure all activities related to the following are completed in accordance with policies, procedures, regulatory requirements and timelines
• Coordinate and/or compile all required documentation/information as requested by Quality Control/Compliance, Corporate Audit, Investor/Agency, MERS, etc.
• Reconcile various Investor reports and custodial accounts according to Agency requirements.
• Obtain Agency approvals, submit reports/files as required by Purchasers/Servicers, Customer notifications, transfer reconciliation and funds settlement, other tasks as detailed on sale schedules.
• Funds reconciliation, Customer notifications, service release reconciliation.
• Review Recast documents for accuracy.
• Compile information and prepare charts/graphs.
• Research of federal/state/agency/insurer requirements to ensure conformity with relevant laws, policies, guidelines and regulations
• Perform disbursement of manual checks and maintain reconciliation log of replacement checks/wires.

Skills on Resume:

• Regulatory Compliance (Hard Skills)
• Account Reconciliation (Hard Skills)
• Agency Approvals (Hard Skills)
• Data Accuracy (Hard Skills)
• Legal Research (Hard Skills)
• Financial Disbursement (Hard Skills)
• Issue Resolution (Soft Skills)
• Cross-Functional Coordination (Soft Skills)

Job Summary:

• Collecting, registering and archiving information and documents in accordance with the applicable GCP (ISO 14155) guidelines for clinical studies
• Support the preparation and maintenance of TMF (trial master file) for the initiation of participating centers in clinical studies and during the execution and closing of the studies
• Participate in projects or initiatives on request, or take on department-wide tasks to contribute to the optimization of processes related to clinical trials
• Co-responsible for maintaining the complete documentation for the studies and for correct study administration in accordance with the SOPs (Standard Operating Procedures), as well as the ICH-GCP guidelines.
• Important tasks in study start-up, (digital) sending, tracing and administration as well as saving of essential documents (e.g. CRFs, CVs, study protocols, investigator brochures, informed consent forms etc).
• May play a role in the filing of adverse effects.
• Collaborate with clinical trial lead, assisting tasks will include setting up systems for filing, document management, document distribution and study management, and preparing, assembling and distributing study materials
• Supports clinical trial lead with clinical study contract management
• Engaged in setting up and maintaining systems for device distribution, traceability and inventory control
• Close follow up with clinical sites on supply status (MemoryBoxes, SD cards, consumables, sensors, ….etc)
• Creates and reviews reports for study center, DSMB member’s compensation and reimbursements
• Identifies and resolves discrepancies

Skills on Resume:

• Information Archiving (Hard Skills)
• TMF Maintenance (Hard Skills)
• Process Optimization (Soft Skills)
• Documentation Compliance (Hard Skills)
• Study Start-Up (Hard Skills)
• Adverse Effects Filing (Hard Skills)
• Document Management (Hard Skills)
• Contract Management (Hard Skills)

Job Summary:

• Early stage engagement with national and international sponsors and academic collaborators on study design, logistics and regulatory requirements
• Prepare and track submissions for Ethical, Health Research Authority and other relevant approvals including Site Specific Assessments, University/NHS Trust Research permissions and NIHR portfolio adoption
• Understanding NHS and University costing processes in order to coordinate complex costings for clinical trials and grant applications (and subsequent amendments)
• Facilitating negotiations with funder representatives and ensuring that adequate funding is agreed
• Taking responsibility for the gene therapy trial pipeline and contribute to the wider multi-disciplinary networks facilitating set up, delivery and participant safety oversight
• Use of advanced communication skills over the life cycle of a study. 
• Preparation, submission and dissemination of study amendments, ensuring that changes are implemented in a timely and accurate manner
• Management of study systems and documentation in accordance with Good Clinical Practice (GCP) including master files, site files, databases, version control and document tracking
• Preparation for, facilitation of and action planning following audits and/or inspections from internal and external parties ensuring that study documentation is presented in accordance with GCP
• Take responsibility for continuous improvement of research administrative processes and target achievement, in line with changing regulations and faculty strategy
• Take responsibility for identifying own learning needs and that of the research team
• Identifying appropriate courses to ensure up to date knowledge of the regulations governing clinical research and research data

Skills on Resume:

• Sponsor Engagement (Soft Skills)
• Submission Tracking (Hard Skills)
• Cost Coordination (Hard Skills)
• Funding Negotiation (Soft Skills)
• Trial Pipeline Management (Hard Skills)
• Advanced Communication (Soft Skills)
• Amendment Management (Hard Skills)
• Audit Preparation (Hard Skills)

Job Summary:

• Document management in accordance with the applicable guidelines for clinical studies - Good Documentation Practices (GCP)
• Set up and maintain clinical investigator files and documentation
• Collaborate with Clinical Trial Leads, set up systems for filing, collect, track and distribute clinical study documents
• Coordinate internal and external stakeholders, facilitating smooth processes and top quality
• Enter and maintain data into selected study tracking databases and ensure a high level of data quality
• Create and maintain systems for study device distribution, traceability and inventory control
• Participate in projects or initiatives on request, or take on department-wide tasks to contribute to the optimization of processes related to clinical trials
• Managing patient visits and conducting study-related procedures.
• Participate in patient recruitment, data entry, and regulatory documentation.
• Oversee phase 3 clinical trials for medical device

Skills on Resume:

• Document Management (Hard Skills)
• File Maintenance (Hard Skills)
• Collaboration (Soft Skills)
• Stakeholder Coordination (Soft Skills)
• Data Management (Hard Skills)
• Inventory Control (Hard Skills)
• Process Optimization (Soft Skills)
• Patient Management (Soft Skills)

Job Summary:

• Assists Study Manager in managing day-to-day responsibilities of clinical studies at investigational sites
• Responsible for coordinating and leading various functional and cross-functional projects and tasks
• Assists in developing protocol and informed consent form and other study-related documents using knowledge of GCP/ICH and other regulatory requirements
• Assists study manager with the investigator contract, budget, and payment process 
• Responsible for initiating and tracking scheduling, payments and subject compensation
• Develops Case Report Forms (CRF), CRF guidelines and other study forms to be utilized by investigational sites
• Proactively identifies and works to resolve enrollment and data completion issues
• Performs manual, in-house review of CRF data for quality, completeness and accuracy
• Completes data entry and data resolution in clinical database
• Coordinates and reviews regulatory documents from investigational sites as well as in-house to ensure compliance with protocol and applicable regulations
• Initiates and tracks device shipments and dispositions and ensures that device supplies are adequate for investigational sites/assigned studies
• Understands study timelines and manages investigational sites to meet enrollment goals and timelines
• Presents at Investigator/Study Coordinator meetings

Skills on Resume:

• Study Management (Hard Skills)
• Project Coordination (Soft Skills)
• Document Development (Hard Skills)
• Contract Assistance (Hard Skills)
• Payment Tracking (Hard Skills)
• Form Creation (Hard Skills)
• Issue Resolution (Soft Skills)
• Data Review (Hard Skills)

Job Summary:

• Assist Clinical Operation functions with day-to-day logistics of assigned clinical studies (study start-up, study execution and close out) including project planning and internal & external communications
• May participate in operational feasibility of the protocols
• Assist with the assessment, selection and management of vendors
• Assist with, or if outsourced assist in overseeing, clinical trial startup activities
• Assist in the development of study related documents and plans and help with distribution and filing
• Support the Clinical Trial Manager in study team activities such as trial documentation management, milestone tracking and identification, resolution and escalation of issues
• Participate in, or if outsourced assist in overseeing, the maintenance and accurate updates of trial level data in CTMS, TMF or other relevant business systems
• Assist with writing routine and ad hoc project updates
• Assist with the preparation for and conduct of internal team meetings, investigator meetings and other trial-specific (cross functional) meetings
• Support in overseeing and tracking site payments and vendor invoices

Skills on Resume:

• Study Logistics (Hard Skills)
• Operational Feasibility (Hard Skills)
• Vendor Management (Hard Skills)
• Startup Activities (Hard Skills)
• Document Development (Hard Skills)
• Team Support (Soft Skills)
• Data Maintenance (Hard Skills)
• Meeting Preparation (Soft Skills)