Position Summary The Department of Surgery, Clinical Transplant Research Core is seeking an individual for the position of Clinical Research Coordinator (CRC) who will report directly to the Director of the Transplant Clinical Research Center. The main role of the CRC will be to operate & maintain the day-to-day operational duties of their assigned clinical trials and clinical research study database.
Responsibilities - Maintenance of detailed study files & complete paper case report forms & uploading of electronic case report forms/data within 48 hours of collection
- Obtain fully informed consent of all eligible trial & study patients in accordance to IRB, local & federal statutes
- Clear and effective communication with potential study subjects, clinicians, other health care providers, ancillary staff, and research office staff.
- Completion and maintenance of the required training for participation in clinical research, including but not limited to: mandatory regulatory training, protocol specific training, ancillary required training per protocol/CUMC
- Collect, process, and assist in the compilation and verification of research data, samples, and/or specimens (following strict protocol and detailed instructions); data is collected through medical chart review, recording of physiologic, imaging data, structured interviews with patients and family members, and conducting all follow up visits in strict accordance with protocol specifications
- Working with regulatory coordinator in submitting new protocols, amendment, renewals, and other regulatory submissions to IRB, sponsor, FDA, and other regulatory bodies.
- Working with Research Director as needed in:
- Coordination of day to day aspects of study related procedures, including, but not limited to: scheduling study subject visits and procedures, data entry, preparation for research visits, research visit documentation, maintenance of regulatory binders and study files, creation and/or maintenance of source documentation, and preparation for monitoring visits, site initiation/closeout visits and audits as needed.
- Handling & processing of human bio-specimens such as blood, saliva, tissue, and stool.
Minimum Qualifications Minimum education: Requires a bachelor's degree or equivalent in education and experience. This opportunity is ideal for individuals who will be applying to residency, foreign medical graduates, or individuals with a graduate health sciences degree or undergraduate health sciences degree and a minimum of 2+ years of clinical research experience. Minimum related experience: Two years of related experience - Working knowledge of MS Office, specifically Word and Excel is required
- Must be able to successfully complete systems training requirements.
Preferred Qualifications - Experience with statistical analysis programs (ie. SAS, SPSS, STATA) is preferred.
Other Requirements - Working knowledge of MS Office, specifically Word and Excel is required.
- Experience with statistical analysis programs (ie. SAS, SPSS, STATA) .
- Intermediate MS Office skills.
- Must be able to successfully complete systems training requirements.
Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents. |
