Junior clinical research associate vs study coordinator

Differences between junior clinical research associate and study coordinator 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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Study coordinator example responsibilities.

• Manage and analyze EKG and sleep data collect from subjects in confidential database.
• Establish and maintain strong community partnerships to achieve HIV prevention objectives.
• Conduct consent discussions and other study procedures per protocol and CFR and GCP guidelines.
• Maintain strict patient confidentiality according to HIPPA regulations, GCP and ICH , 21 CFR and other regulatory documentation.
• Maintain accurate IRB, regulatory and study documentation to insure compliance with protocol and good clinical practice guidelines.
• Coordinate day-to-day study activities including data collection and statistical analysis, protocol development/implementation, IRB relations, and staff development.
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