Clinical trials specialist vs clinical coordinator

Differences between clinical trials specialist and clinical coordinator duties and responsibilities

Clinical trials specialist example responsibilities.

• Manage all clinical data and subject source documentation through the EDC system to verify compliance and subject eligibility.
• Lead study data management activities for oncology trials in preparation for study close-out.
• Review clinical study documents for completeness and compliance with protocol, FDA regulations, ICH and GCP guidelines.
• Perform routine quality control (QC) of TMF and submit documents to ensure overall quality.
• Review ICF and study reports and find discrepancies that are missed by CRO management.
• Collect, review, approve and track in CTMS regulatory essential start-up and amendment documents.
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Clinical coordinator example responsibilities.

• Manage chronic illnesses such as hypertension, coronary disease and diabetes.
• Create and manage case report forms and transmit data through EDC to sponsor.
• Manage patient telemetries systems to include EKG's, vitals, INR management and sleep monitoring systems.
• Manage the CRA team and serve as main point of contact for study logistics and relate questions including subject eligibility questions.
• Manage common side effects of chemotherapy and experimental therapies.
• Manage the clinical reimbursement coordinators traveling schedule to ensure that facilities have adequate MDS coverage.
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