Clinical Trial Associate

About the role:

This is a multi-faceted position with exposure to all aspects of running a clinical trial.  There will be an opportunity for continual interactions with other functional departments and external vendors.  The CTA will work in a dynamic environment with the opportunity to learn the day-to-day activities required to coordinate and manage a clinical trial.   The CTA will work with Global Clinical Project Manager and Clinical Trial Manager to assure the time-sensitive and successful operation of a clinical study.  There is opportunity for growth and to assume new responsibilities commensurate with the individual’s abilities.

The broader IDRx team works primarily remotely and meets in-person in Cambridge, MA once monthly. Opportunities for more frequent in-person collaboration and engagement are possible and are driven by individual interest and availability.

Responsibilities:

• Administer, maintain, and coordinate the logistical aspects of clinical trials and participate in a variety of clinical activities to support and facilitate the efficient conduct of IDRx’s clinical research programs
• Adhere to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMA, GCP, and ICH guidelines
• Assist in the coordination and tracking of clinical supply shipments, equipment, and study-specific laboratory samples
• Assist the Clinical Trial Manager (CTM) and Global Clinical Project Manager in preparing Protocols, Informed Consent Forms, Investigator Brochures and other study documents, and track revisions and versioning
• Support the CTMs in the set up and maintenance of study electronic filing systems (eTMF) compliant with regulations and in audit ready state, as well as general study filing
• Ensure that tracking tools are developed and maintained throughout the trials for the Clinical Operations teams
• Day-to-day contact with counterpart at CRO; daily review and identification of potential issues or problems with the sites and communicate/escalate to CTM or senior Clinical Operations staff
• Provide oversight of activities related to safety reporting compliance
• Review and maintain SOP and study-level training documentation
• Review study-specific essential regulatory document packets prior to site activations
• Post, update, and maintain information on clinicaltrials.gov registry(ies) and other registries as appropriate
• Act as Functional TMF Document Specialist for Clinical Operations, to include submission of documents to and maintenance of the Trial Master File (TMF); review TMF documents as part of the Quality Review Process
• Act as primary liaison with the CRO to collect trial documents and coordinate review of the electronic TMF to ensure inspection readiness at all times
• Manage insurance certificate requirements
• Obtain and disseminate schedules and calendars; prepare and distribute agenda and minutes for project team meetings and client meetings, and assist with tracking of action items

Requirements:

• Bachelor’s degree in scientific, biological, life sciences, or related field and 1+ year experience in relevant field (e.g.clinical site, CRO, sponsor or clinical trial vendor).
• Familiarity with ICG, GCP, and FDA requirements, as applicable, for clinical trial management.
• Strong skills in collaboration, communication, organization, attention to detail and multi-tasking.
• Sound analytical and problem-solving skills; ability to act with a consistent sense of urgency.
• Ability to work effectively in a fast-paced, cross-functional environment and demonstrate ability to manage changing timelines and priorities.
• Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint, SharePoint).
• Previous experience working in oncology.