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Clinical Trials Coordinator
2 months ago
Position Overview:
The Clinical Trials Coordinator plays a crucial role in ensuring that Institutional Review Board (IRB) approved protocols are effectively executed and adhered to. This position involves overseeing the informed consent process, monitoring patient safety and status, and systematically collecting and organizing research data.
Key Responsibilities:
● Prepare study sites for research activities.
● Facilitate the informed consent process, including patient screening and recruitment.
● Manage patient enrollment and conduct study-specific visits.
● Oversee the maintenance and distribution of study products and supplies.
● Ensure the accuracy and quality of case report forms.
● Maintain comprehensive source documents.
● Uphold site quality standards.
● Develop and maintain a thorough understanding of protocol requirements and schemas.
● Collaborate with healthcare professionals to ensure strict adherence to protocols and provide resources to staff members.
● Draft patient information sheets for clinical studies for IRB submission, ensuring timely completion of necessary documents.
● Participate in creating and implementing educational materials for patients.
● Review research and administrative documents to identify action items, prioritizing and tracking them accordingly.
● Responsible for the completion, submission, and tracking of regulatory documents to the IRB.
● Maintain and update research funding accounting files, including billing, budgets, and fund transfers.
● Respond to data and informational requests.
● Analyze statistical, resource, performance, and budget data, generating comprehensive reports.
Qualifications:
● 1-2 years of experience as a Clinical Research Coordinator (CRC) or in a relevant field is preferred.
● A Bachelor’s degree is required; a Master’s degree in a related field is preferred.
● Strong working knowledge of Good Clinical Practice (GCP) is essential.
