Under the direction and supervision of the Director of Clinical Operations, Manager of Clinical Operations and Principal Investigator, the Clinical Research Coordinator I (CRC I) is responsible for providing support for clinical research protocols. The CRC I facilitates all implementation phases of new clinical research studies as well as the ongoing coordination and maintenance of open and closed studies. The position arranges and oversees all clinical trial activities and plays a key role in assisting the Principal Investigator (PI) in recruiting patients for clinical studies. The position works closely with the Principal Investigator, members of the department, study sponsors and monitors, and the institution, to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of all ongoing clinical studies. This individual will interact with subjects, clinic and research staff, laboratory staff, radiology staff and any other medical professionals associated with our clinical research protocols.
The Clinical Research Coordinator fulfills the requirements of recruiting, enrolling and conducting follow-up of study participants in clinical trials related to all therapeutic areas represented throughout MemorialCare. In doing so, the Clinical Research Coordinator I is responsible for coordinating trial participation of study volunteers with the trial’s protocol, company and trial Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines, FDA regulations and other applicable regulations (global, state, etc.). The Clinical Research Coordinator I is responsible for working with the trial delivery team to meet enrollment and retention goals and ensure compliance with the study protocol. After hours support and coverage may be needed to adequately meet the needs of the research subject and/or adhere to the protocol recruitments. After-hours Support Staff will be compensated for his/her time providing support during these after hours.
* Minimum of two (2) years of clinical research experience required.
* Knowledge of clinical trial federal, state and local regulation requirements preferred.
* Excellent interpersonal and communication skills required.
* Ability to read and understand clinical trial protocols required.
* Strong data management skills and attention to detail required.
* Familiarity with medical terminology/environment required.
* Extensive knowledge of Microsoft Office (Word, Excel, and Adobe Acrobat) required.
* Associates degree or equivalent education required.
* Bachelor’s degree in relevant field preferred.
* Research certification (e.g. ACRP, SoCRA or equivalent) preferred.
* Phlebotomy certification preferred.
* Current CITI training preferred.
* Must maintain a valid driver’s license and automobile insurance as travel to physician offices and health system locations is required for departmental specific job duties.
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