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.

• Responsible for the quality deliverables at the country level; follows project requirements and applicable country rules with moderate oversight from the SSU Country Manager
• Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time
• Investigates and provides clear rationale for delays, provides support on contingency plan to mitigate impact, and escalates the issue as soon as identified
• Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion
• Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance
• Supports continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned
• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements
• Responsible for the Local Submissions Specialist - Follows the project direction provided by the designated country start-up advisor (CSA) and SAM
• May serve as a point of contact for the PM/SAM (or designee) during start-up on allocated projects

Clinical Trial Associate responsible for country-level deliverables in clinical trials

Clinical Trial Associate – Single Sponsor Support

Clinical Trial Associate responsible for quality deliverables in clinical trials for Syneos Health. Collaborating with teams to ensure compliance with timelines and quality standards.

Clinical Trial Associate jobs in Florida

See all jobs on JobTailor

Senior Clinical Trial Associate

Clinical Trial Associate – Single Sponsor Support