Clinical Trial Associate

Role Summary

Clinical Trial Associate

Responsibilities

• Provide support for critical day-to-day clinical study activities, including inspection readiness and/or oversight of inspection deliverables and/or milestones, in accordance with established protocols under the general supervision of the CTA Manager.
• Collaborate with the Clinical Trial Manager, study teams, vendors, and Clinical Research Organizations (CROs) to support clinical study activities defined by the clinical trial operating model.
• Supported the clinical trial manager with preparing and coordinating bi-weekly clinical trial team meetings and finalizing meeting materials such as agendas, slides, and meeting minutes; tracked and followed up on action items.
• Development and/or review and approval of study documentation, including essential document packets, study plans, informed consent forms, etc.
• Contribute to the writing and review of clinical documents such as protocols, informed consent forms, investigator brochures, trial reports, ASRs/DSURs, laboratory manuals, pharmacy manuals, and trial status updates.
• Ensure audit-ready condition of clinical trial documentation, including the trial master file, and leading internal TMF quality reviews with cross-functional team members on the study-defined cadence.
• Track patient samples and reconcile sample discrepancies with sites and applicable central labs; coordinate sample movement and data deliverables on time with business needs and accompanying data deliverable timelines.
• Assist the finance department with invoices, clinical projections, and per-patient cost estimates.
• Work closely with the CRO to support study and site start-up activities such as SIV slide development, process flows, contract and budget negotiations, site ICF customizations, assist with answering site IRB questions, etc., to ensure start-up occurs within an established timelines.
• Review and provide input on clinical monitoring visit reports and ensure that all outstanding follow-up items are closed out in a timely manner.
• Collaborate with internal departments (Legal, Finance, Nonclinical, etc.), CROs, and external vendors.
• Establish and maintain trial-related processes/systems with study vendors such as central labs, clinical supplies, IP depot, and CRO as assigned per protocol requirements.
• Help develop and drive timelines and collaborate with cross-functional teams to align on deliverables to help support data cuts, conference needs, interim analyses, etc.
• Monitor the progress of clinical study activities and report on the progress of assigned clinical trials, including budget and timelines.
• Oversee the updating and maintenance of patient trackers to accurately reflect all enrolled, screened, and screen-failed patients within the study. Ensure timely completion of patient visits and proactively follow up with sites and CROs regarding any outstanding visits. Provide real-time patient updates to the Clinical Trial Team as needed
• Initiate clinicaltrials.gov updates and publications based on business needs and other study updates.
• Participate in the preparation and review of SOPs.
• Perform any other business need identified by their direct line Manager.

Qualifications

• BA/BS required
• Understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies globally.
• Strong knowledge of MS Word, Excel, PowerPoint, and Outlook.
• Ability to effectively collaborate with both internal and external study team.
• Ability to take initiative and ownership of new activities as they arise.
• Ability to work in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands.
• Experience working on project teams is required.
• Candidate should be a self-driven individual with skills in organization, building working relationships and communication.