The Clinical Trial Coordinator role will provide support for the day-to-day operations of the Clinical Development and Clinical Development Operations (CDO) team and will also assist with the execution and maintenance of clinical trials in accordance with ICH GCP, AGTC SOPs and local regulations. The position is based in the Cambridge, MA office.
- The Clinical Trial Coordinator reports to the Associate Director Clinical Project Management or designee
Duties and Responsibilities
- Serves as a member of the CDO team with the goal to contribute towards efficient management of clinical trials.
- Support Operational teams in the conduct of study team meetings through drafting agendas and meeting minutes, preparing and distributing materials, and managing meeting logistics (meeting room, calendar invites) for both internal and external attendees.
- Supports Clinical Project Managers and Clinical Trial Managers in the development, review, maintenance, quality control, distribution, and archiving of clinical study documents and reports.
- Proofreads slide decks and other study documents for grammar, punctuation, calculations, spelling, etc, as well as overall completeness and accuracy.
- Participates in study team meetings on assigned studies and programs. Prepares and distributes meeting agendas, minutes, and other meeting materials as needed.
- Assists in the development of program specific standards (e.g., agendas, minutes, filing structure, and team materials).
- Sets-up, maintains and archives the Trial Master File (TMF) in compliance with ICH, GCP and AGTC SOPs. This may include the review and tracking of clinical trial documents in coordination with vendors and the CRO.
- In collaboration with the Clinical Trial Manager and Clinical Project Manager, prepares and conducts relevant QC checks of the Trial Master File.
- Updates the Essential Document Tracker in a timely manner ensuring documents are filed within the TMF upon receipt.
- Manages inventories for clinical trial supplies, including the tracking and shipment of investigational product.
- Coordinates local, virtual, or off-site meeting/event logistics (including scheduling meetings, preparation of relevant materials, room reservations, IT/AV support, etc.)
- Manages and maintains study team and site contact lists, calendars, organizational charts, etc.
- Collaborate closely with the Clinical Operations team, cross-functional study teams (internal/external) and CRO partners to support the execution of clinical studies.
- Actively participate and contribute ideas in the development of department initiatives and goals.
- Assist/oversee in the creation and maintenance of databases or tracking tools used to manage assigned studies.
- Track and report on progress of assigned studies and programs, including site activation, patient enrollment and monitoring visits.
- Assemble and distribute site regulatory binders to clinical sites.
- May serve as an office-based secondary point of contact for sites during the course of the study, in addition to providing phone coverage for travelling team members.
- Develops and maintains good working relationships with investigators and study staff to promote AGTC's high quality and ethical image.
- Assist with processing of site contracts, and payments and other regulatory documents as needed.
- Assist with IRB applications
- Create and maintain entries in clinicaltrials.gov
- Other duties as assigned.
- This job description is subject to change at any time.
- Bachelor's degree
- Bachelor's degree life sciences is strongly preferred
- Two (2) years' experience preferred in clinical research or relevant administrative experience.
- Excellent written and oral communication skills, as well as time management skills.
- Demonstrates the ability to multitask under compressed deadlines across several projects, each with unique requirements.
- MS Office proficient
- Physical demands: (check one)
☒ sedentary ( 10 lbs.)
☐ light work ( 20 lbs.)
☐ medium work ( 50 lbs.)
☐ heavy work ( 100 lbs.)
☐ very heavy work ( 100 lbs.)
- Physical activity: (check all that apply)
- Visual acuity: reading, writing, preparing/analyzing data
- Working conditions: indoor office environment
- No previous supervisory experience required