Clinical trials associate vs clinical coordinator

Differences between clinical trials associate and clinical coordinator duties and responsibilities

Clinical trials associate example responsibilities.

• Manage trial master files and study document to meet GCP/ICH and internal guidelines for records retention.
• Audit TMF to ensure all require regulatory documentation are collected and lead.
• Work closely with investigators to recruit eligible patients to clinical protocols, manage data collection and preparation.
• Preform ICF customization in accordance with ICH guidelines, GCP s and local regulatory requirements.
• Support the setup, data entry and QC of the system to ensure accuracy and quality of data.
• Monitor clinical data and resolve inconsistencies according to FDA regulations and ICF guidelines.
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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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