Junior clinical research associate vs clinical project manager

Differences between junior clinical research associate and clinical project manager duties and responsibilities

Junior clinical research associate example responsibilities.

• Coordinate and manage multiple clinical studies for safety assessment of products with CRO.
• Supervise and manage planning, implementation, conduct and reporting of assign early phase international clinical studies in oncology.
• Preform protocol require basic medical evaluations such as blood pressure and ECG's as well as dispensing study medication.
• Conduct initiations, interim site visitations and audits of CRO for GCP compliance.
• Review & provide quality management of electronic clinical study data and generate queries on multiple EDC systems.
• Recruit investigators perform pre-study visits, negotiate budgets, initiate and monitor studies and verify data for accuracy and completeness.
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Clinical project manager example responsibilities.

• Develop, manage, motivate and ensure professional development of project staff (13 CRAs).
• Manage domestic and international oncology clinical study sites.
• Manage multiple pharmaceutical studies ensuring compliance with FDA guidelines.
• Manage the operational aspects and execution of clinical studies focusing on oncology.
• Supervise rotating team of CRA's contract with the CRO, educating on therapeutic area, and ensuring ICH GCP compliance.
• Ensure GCP / ICH regulatory compliance on studies, preventing study deviations and provide swift resolutions to possible violations.
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