Clinical Research Coordinator 2 Jobs

BSD MED - Rheumatology
The Section of Rheumatology was formed in 1967 when the Divisions of Metabolism and Rheumatology were combined into one Section with two Section Chiefs: Drs. Leif Sorensen and Dan McCarty. During this time, the faculty including Attalah Kappas, M.D. and Rudi Schmid, M.D. made important contributions to the understanding of several metabolic diseases. Dr. Sorensen then went on to be the Vice Chair of the Department of Medicine for 20 years and the Chair in 1997. In 1980, Dr. Michael Becker became the Section Chief and served until 2000. The current Section Chief is Marcus Clark, M.D.
The Clinical Research Coordinator 2 (CRC2) is a specialized researcher partnering with the clinical Principal Investigator (PI) and under the direction of a departmental or lab research manager. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC2 supports, facilitates and coordinates independently the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties with limited supervision and/or guidance, the CRC2 works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.

• Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.
• Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
• May assist in the training of new or backup coordinators.
• Recruit and interview potential study patients with guidance from PI and other clinical research staff.
• Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.
• Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.
• Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.
• Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.
• Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
• Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.
• 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.
• Performs other related work as needed.
• Identify and explain the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
• Coordinate the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.
• Organizes and attends site visits from sponsors and other relevant study meetings.
• Performs assessments at visits and monitors for adverse events.
• Ensures compliance with federal regulations and institutional policies.
• May prepare and maintain protocol submissions and revisions.
• 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.

Minimum requirements include a college or university degree in related field.Minimum requirements include knowledge and skills developed through < 2 years of work experience in a related job discipline.
Research
Individual Contributor
Exempt
Monthly
40
Yes
Yes
Yes
No