Job Details
The Department of Medicine (DoM), Clinical Research Hub (CRH) at Stanford University is seeking a Clinical Research Coordinator Associate to perform duties related to the coordination of clinical studies in the disciplines of Infectious Disease and other therapeutic areas. This role will work in both inpatient and outpatient settings on a variety of interventional and observational clinical research trials and studies. This is an onsite role, with direct patient contact being a primary responsibility. The ability to coordinate moderately complex aspects of one or more clinical studies, ability to task switch in a high-energy environment, outstanding communication and organizational skills, and attention to detail are required in a successful candidate. The CRCA will present updates at study meetings and huddles, and be responsible for ensuring compliance with federal, state, local, institutional and sponsor regulations; and work under close direction of the principal investigator and/or study coordinator/supervisor. Other duties may also be assigned.
Responsibilities
Core Duties:
- Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through closeout.
- Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
- Coordinate collection of study specimens and processing.
- Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
- Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions and ensure Institutional Review Board renewals are completed.
- Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
- Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
- Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
- Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
- Participate in monitor visits and regulatory audits.
Minimum Education and Experience
Two-year college degree and two years related work experience or a bachelor’s degree in a related field or an equivalent combination of related education and relevant experience.
Knowledge, Skills and Abilities
- Strong interpersonal skills.
- Proficiency with Microsoft Office.
- Knowledge of medical terminology.
Certificates and Licenses Required
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
Organization
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