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 either the Cambridge, MA office or Alachua, FL headquarters.
The Clinical Trial Coordinator reports to the VP, Clinical Development Operations.
Essential Duties and Responsibilities
- Serves as a member of the CDO team with the goal to contribute towards efficient management of clinical trials.
- Facilitates CDO meetings with respect to the preparation and distribution of materials and final meeting minutes, as well as the coordination of participant attendance.
- Supports all MDs, including the CMO and the CDO team with calendar maintenance and meeting scheduling. Prepares/submits expense reports.
- 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 prepares for relevant QC checks and archives the Trial Master File (TMF) in compliance with ICH GCP and AGTC SOPs.
- 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 or off-site meeting/event logistics (including scheduling meetings, preparation of relevant materials, room reservations, IT/AV support, etc)
- Manages and maintains team and site contact lists, calendars, organizational charts, etc.
- 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.
- Performs other duties as assigned.
- Bachelor’s degree (life sciences/health care field is a plus), or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities.
- Minimum of 2 years’ experience in clinical research or relevant administrative experience.
AGTC offers a competitive compensation commensurate with education and experience, including salary, benefits, and company equity. AGTC is an EOE and maintains a drug-free workplace. Please send CV or resume to: firstname.lastname@example.org