Coordinate clinical protocol subjects, perform screening and consent, and manage data collection for the Transplant Center. Ensure regulatory compliance with GCP and HIPAA guidelines while assisting in protocol development and IRB submissions.
Requirements summary
Requires an associate's degree or allied health professional degree with one year of relevant experience. Preferred candidates have experience as a research coordinator and proficiency in managing patient databases.
Associate's degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience.
Job Description
Seeking qualified candidates for a Clinical Research Coordinator I (CRC I) position within the Transplant Center, Department of Surgery, Division of Transplant Surgery under the direction of the Investigator. As part of an interdisciplinary health team, the incumbent will collaborate with other CRCs, physicians, nurses, and other key personnel in the department and clinic to ensure compliance with protocol requirements and satisfactory care for enrolled patients. The incumbent will also assist in the development of protocol methodologies and data collection.
Job duties include, but are not limited to
Coordination of
Protocol
Subjects &
Data
Collection:
Perform subject screening and consent for clinical protocols under direction of the Principal Investigator (PI)
Serve as patient resource and educator for information regarding the study and/or clinical symptoms.
Prepare and ship central laboratory samples as per protocol requirements.
Collect baseline and follow-up data from the medical record.
Document findings in appropriate source records and case form reports.
Schedule and attend clinic appointments for patients as required by protocol.
Assist with operating room protocol requirements where appropriate.
Coordination of Protocol Compliance
Maintain knowledge base of Good Clinical Practice Guidelines and Federal Code of Regulation regarding clinical trial conduct.
Coordinate and maintain HIPAA compliance for assigned studies.
Communicate with interdisciplinary health team in care of patients involved in research studies to ensure regulatory compliance.
Interact with local laboratories and diagnostic study centers to ensure clinical protocol requirements are complete for studies.
Coordinate efforts of Investigational Pharmacist and maintains site records for Good Clinical Practice and sponsor guidelines.
Research Support
Assist medical and scientific partners to design protocol methodologies for basic science, preclinical studies, and clinical protocols.
Help with protocol development and endpoints to ensure statistical and clinical relevance of studies.
Assess clinical needs by performing literature review and discussion with faculty advisors within the Division.
Prepare and submit filings of protocols to the Investigational Review Board (IRB) and Animal Care Committees as needed.
Design Case Report Forms and Source Documents for clinical protocols where required.
Assist with grant development projects as needed for preclinical studies with the Division.
Assist with manuscript preparation and abstract submission for PIs.
Track the type of study services performed to ensure that they are compensated appropriately.
Other duties as assigned.
Expected Salary: $46,000-$53,000
Required Qualifications
Associate's degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience.
Preferred
Excellent communication skills; must be able to communicate with patients and family participating in clinical trials.
Experience as a research coordinator preferred.
Experience with patient data and/or databases.
Proficient time management skills and ability to successfully manage multiple studies.
Special Instructions to Applicants
In order to be considered, you must upload your cover letter, resume, and 3 references with contact information
