Clinical Trial Associate

• Coordinates and tracks the distribution and subsequent retrieval of clinical documents, including but not limited to protocols, protocol amendments, IBs, ICF’s, monitoring visit reports, etc.
• Supports maintenance of inspection-ready Trial Master File (TMF) according to ICH-GCP and company SOPs
• Performs quality checks on the study TMF with oversight of study Clinical Operations Lead (COL)
• Assists in the preparation of study related documents, i.e., ICF, clinical trial tools and templates, etc.
• Coordinates and tracks clinical trial equipment and supplies
• Coordinates and tracks shipments of drug supply
• Reviews and tracks vendor invoices against contracts with oversight of study Clinical Operations Lead
• Coordinates and tracks administrative aspects of contract execution and Purchase Order (PO) generation
• May support and participate in departmental/cross-functional process improvement initiatives
• Supports the trial team to produce and distribute study newsletters
• Assists with various supportive trial activities, i.e., meeting management including agenda distribution and minute taking, internal database maintenance, study team contact list, etc.
• Serves as point of contact for 1 or more low to medium complexity vendors with oversight of study Clinical Operations Lead
• Liaises with clinical trial sites as required

Senior Clinical Trial Associate coordinating and managing clinical trials at Sarepta

Senior Clinical Trial Associate

Senior Clinical Trial Associate managing clinical trials for genetic medicine in the USA. Supporting document coordination, quality checks, and vendor management in a hybrid role.

• Support day-to-day clinical trial operations in alignment with protocols, timelines, and regulatory requirements.
• Serve as a point of coordination across internal teams, CROs, and external partners.
• Maintain the Trial Master File (TMF), ensuring completeness, accuracy, and audit readiness.
• Perform TMF quality control activities and proactively address gaps.
• Support audits and inspections, including preparation and follow-up activities.
• Coordinate with vendors, including central labs and specialty service providers.
• Support biospecimen tracking, logistics, and associated documentation.
• Track and monitor vendor performance and escalate issues as needed.
• Develop, maintain, and improve study tracking tools (e.g., enrollment, sample tracking, timelines).
• Ensure data accuracy and timely reporting across study activities.
• Contribute to improvements in clinical operations processes and systems.
• Facilitate clear, timely communication across study teams and stakeholders.
• Coordinate study meetings, including agenda development, minutes, and follow-up actions.
• Maintain version control and documentation across clinical materials.
• Support invoice tracking, purchase order coordination, and budget-related activities.

Clinical Trial Associate supporting oncology clinical trials at Obsidian Therapeutics

Clinical Trial Associate – Oncology

Clinical Trial Associate supporting oncology clinical trials at Obsidian Therapeutics. Coordinating clinical trial operations and ensuring compliance with protocols and regulations.

• Actively engages in site management activities, including assisting with site regulatory startup (including ICF review), providing oversight for site-level IRB submissions, managing site communications, and conducting onsite or remote investigator site file (ISF) reviews.
• Leads meeting coordination activities, including preparing agendas, facilitating discussions, and documenting key decisions and action items.
• Provides support for site training by presenting GCP/GDP requirements, study-specific logs, and ISF expectations to ensure alignment with protocol and regulatory requirements.
• Supports coordination of Investigational Products (IP), focusing on the documentation and tracking.
• Tracks and reports on key study metrics (e.g., regulatory package status, TMF accuracy/completeness/quality, site statuses) and provides regular updates to leadership with proposed mitigation strategies.
• Supports inspection readiness and audit preparation by conducting internal reviews, preparing team members, and participating in mock audits to ensure a continuous state of readiness.
• Maintain and organize TMF, including identifying and resolving TMF gaps, ensuring documents are complete, accurate and inspection ready.
• Contributes or authors key study documents, including Informed Consent Form (ICF)/Assent, study plans, and study-related templates.
• Supports CRAs in monitoring visit execution by performing eISF reviews and providing TMF vs ISF reports to ensure completeness.
• Manages day-to-day interactions and deliverables for third-party vendors (e.g., central labs, imaging) to ensure adherence to study timelines.
• Reviews vendor-specific documentation for accuracy and ensures relevant records are filed in the TMF.
• Contributes to departmental operations and process improvements, including SOP authorship, development of templates and tools, and optimization of systems.
• Maintains and supports clinical systems (e.g., CTMS, Smartsheet) ensuring accuracy of metrics.
• Oversees study training compliance by developing and maintaining study training matrixes and curriculum maintenance.
• Manages Central IRB activities across programs, including submission oversight, tracking approvals, and maintaining cross-functional IRB trackers.
• Performs contractual management, PO management, invoice tracking, and site payments.
• Performs Protocol Deviation management, data review, medical review committee submission management, and ClinicalTrials.gov maintenance.
• Coordinates planning for Investigator Meetings and specialized Surgeon Training.

Clinical Trial Associate managing daily activities across clinical studies at Vericel Corporation

Clinical Trial Associate managing daily activities across clinical studies for regenerative medicine at Vericel Corporation. Ensuring compliance with protocols, regulatory requirements, and Good Clinical Practices while leading key site management activities.

Clinical Trial Associate jobs in Massachusetts

See all jobs on JobTailor

Senior Clinical Trial Associate

Clinical Trial Associate – Oncology

Clinical Trial Associate