- UNBLINDED study experience
- Experience w/ IP documents
- Past experience in Vault
- Motivated, and willing to work independently
- Assist the Clinical Operations Lead(s) (COL) and/or Clinical Trial Manager(s) (CTM) in the day-to-day operational activities of assigned trials to ensure study objectives and timelines are met with quality, in compliance with applicable SOPs and regulatory guidelines
- Maintain clinical trial files (including eTMF), project processes, tracking systems, and other utilized study or departmental systems
- Liaise with Clinical Sample Management for the tracking and coordination of biomarker testing with 3rd party labs
- Collaborate with Clinical Data Management and Digital Informatics to ensure timely training and access to systems (e.g., EDC, IWRS, ePRO, eTMF) for external stakeholders (e.g., CRO and Clinical Site Staff)
- Coordinate Project Team and departmental meetings, including associated documentation
- Assist with vendor / clinical site agreements, budgets and reconciliation / tracking of purchase orders and invoices for assigned trials
- Develop and maintain strong, collaborative relationships with key stakeholders within its CROs, and clinical sites
- At least 2 years of experience in a clinical research environment
- Bachelor's degree in a science-based discipline preferred
- Basic understanding of drug development, including familiarity with FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
- Good verbal and written communication skills
- Good organizational skills and attention to detail
- Willingness to learn, able to take direction and ability to manage multiple tasks
- Self-motivated and comfortable with shifting priorities and change in a small company environment
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Clinical Operations Analyst
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Director, Clinical Operations
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Director Clinical Operations
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The Steely Group Cambridge, United StatesReporting to the Director of Clinical Operations, this role is responsible for collaborating with and utilizing instructions/ information from study managers or global project leaders to support Clinical Operations by ensuring the timely and effectiv Clinical, Operations, Clinic, ...
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Associate Director, Clinical Operations
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Director, Clinical Operations Excellence
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Director, Clinical Supply Operations
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FogPharma Cambridge, United StatesWhy Join Us?FogPharma is a biopharmaceutical company pioneering the discovery and development of HeliconTM therapeutics, which are peptides capable of efficient cell entry and modulation of both protein-protein and protein-DNA interactions. Through Helicon therapeutics, FogPharma ...
Clinical Trial Associate, Clinical Operations - Cambridge, United States - Randstad Life Sciences US
Description
A major Pharmaceutical company, From accelerating drug discovery and early development to a rapidly expanding pipeline and a world-class team, delivering on the promise of treating infectious and other diseases.
SKILLS:
Job Summary
The Clinical Trial Associate (CTA) provides clinical trial coordination support to Project Teams for assigned clinical trial(s). This support includes tracking a wide range of key operational activities and maintenance of essential study documentation, including the electronic Trial Master File (eTMF). This position will work with internal team members and with external vendors and CROs. The position reports to the Clinical Operations Head in the assigned Therapeutic Area and will work cross-functionally and collaboratively to support clinical operations activities.
Job Responsibilities
Education & Qualifications
Clinical Trial Associate, Clinical Operations professionals in Cambridge
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Rick Zhou
Private Equity Analyst