Clinical Research Coordinator

Clinical Research Coordinator 1519284

• Hourly pay: $40/hr
• Worksite: Leading university (Palo Alto, CA 94304 - Hybrid)
• W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
• 40 hours/week, 6 Month Assignment (With possibility of extension)

A leading university seeks a Clinical Research Coordinator to coordinate clinical studies from start-up through closeout, including participant enrollment, data management, and regulatory compliance.

Clinical Research Coordinator Responsibilities:

• Coordinate moderately complex aspects of one or more clinical studies from start-up through closeout under close direction of the principal investigator and/or study coordinator/supervisor, serving as primary contact with research participants, sponsors, and regulatory agencies, and interacting regularly with the principal investigator to ensure patient safety and proper study conduct.
• Determine participant eligibility and gather consent according to protocol, assist in developing recruitment strategies, and coordinate the collection and processing of study specimens.
• Collect and manage patient and laboratory data, manage research project databases, develop flow sheets and other study-related documents, complete case report forms, and ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
• Ensure compliance with research protocols, review and audit case report forms for completion and accuracy against source documents, prepare regulatory submissions, ensure Institutional Review Board renewals are completed, and participate in monitor visits and regulatory audits.
• Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors as primary contact. Monitor expenditures and adherence to study budgets, resolving billing issues in collaboration with finance and/or management staff.

Clinical Research Coordinator Qualifications:

• 2 years of related work experience and a two-year college degree; OR
• Bachelor's degree in a related field; OR
• Equivalent combination of related education and relevant experience.
• Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) certification is preferred.
• Clinical research assistant and data entry experience.
• Experience working with electronic medical records.
• Knowledge of medical terminology and proficiency with Microsoft Office.
• Experience with EPIC is preferred.
• Ability to pull objects up to 40 pounds.

Shift:

• Hybrid: onsite 3-4 days/week. Day Shift.