The Clinical Research Coordinator II is a specialized researcher partnering with the clinical Principal Investigator and under the direction of a departmental or lab research manager. The CRC II supports, facilitates, and coordinates independently the daily clinical trial activities and plays a critical role in the conduct of the study.
Requirements
- Manages all aspects of conducting clinical trials including screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
- Recruit and interview potential study patients with guidance from PI and other clinical research staff.
- Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.
- Coordinate the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, coordinating reimbursement, and serving as the primary patient liaison for study-related inquiries and support while ensuring protocol adherence.
- Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.
- Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures.
- Performs assessments at visits and monitors for adverse events.
- Organizes and attends site visits from sponsors and other relevant study meetings.
- Controls the acquisition/collection, abstraction, processing, privacy, and quality assurance for all clinical research data required for the protocol.
- Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.
- Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.
- Works closely with Regulatory Manager to maintain accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, and study related communication.
- Understand the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions independently.
- Ensures compliance with federal regulations and institutional policies.
- Accountable for all tasks in moderately complex clinical studies.
- Assists with various professional, organizational, and operational tasks under moderate supervision.
- Performs other related work as needed.
Benefits
- Paid time off
- Health insurance
- Retirement plan
- Salary
