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Clinical Trial Associate
Posted 8 days agoViewed
🔍 Industry: Biopharmaceutical
🏢 Company: Disc Medicine👥 51-100💰 $225,500,000 Post-IPO Equity 2 months agoPharmaceuticalBiotechnologyTherapeuticsMedicalHealth Care
🗣️ Languages: English
Requirements:
- 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.
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 timeline.s
- 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.
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