Clinical trials associate vs research coordinator

Differences between clinical trials associate and research 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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Research coordinator example responsibilities.

• Manage participant's records ensuring confidentiality as well as NIH specifications.
• Manage all IRB submissions, sponsor communications, participate in monitoring visits, drug reconciliation and dispensing.
• Recruit, screen, conduct psychometric examinations and collect data for pharmaceutical clinical trials in patients diagnose with Alzheimer's disease.
• Maintain confidential information and appropriate ethical professionalism with highly sensitive personal health information; take part in IRB human subjects training.
• Assist in preparation of grants, NIH progress reports, presentations, and manuscripts.
• Ensure and maintain confidentiality, privacy and compliance of patient rights in accordance with HIPAA regulations and NVCI policies.
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