Junior clinical research associate vs clinical trial manager

Differences between junior clinical research associate and clinical trial 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 trial manager example responsibilities.

• Manage SAEs and assure they are properly record and report.
• Manage CRO vendors and ensure timely execution of study milestones.
• Manage assign independent consultants and employee CRAs regarding project-relate issues.
• Lead study data management activities for oncology trials in preparation for study close-out.
• Ensure study adherence to all regulatory matters and sponsor requirements according to FDA regulations, GCP and ICH guidelines.
• Create document templates require by FDA and ICH regulations for site distribution.
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