The research coordinator’s main function is to advance clinical research studies for outpatient and inpatient departments of The Guthrie Clinic. Weekly travel between sites in Sayre, PA and Binghamton, NY is required.
Knowledge of federal regulations related to research, documented experience with study coordination, and documented training of Good Clinical Practice research standards training. The completion of CITI Basic Research course regarding Human Subject’s Protection Training is required within one month of employment.
Must meet one of the following categories: Five years’ experience in a Clinical Research office with certification as a Clinical Research Professional, or Associate Degree in applied science with five years’ experience in the medical field, or Bachelor of Science degree with one-year experience in a research facility/hospital setting.
Coordinate specific projects. Project coordination requires meeting sponsor specific training requirements prior to initiation, assuring team members have met sponsor training, training team members to delegated duties, supporting regulatory specialist with sponsor communications, maintaining study supply inventory, and supporting monitors during visits. Coordinate individual research participant’s visits.
This coordination for the patient includes screening, enrolling, organizing patient visits to meet study requirements at specific protocol timelines, performing patient interviews related study assessments, dispense prescribed study medication, determine medication compliance, and follow-up on correspondences with patients related to the study. Perform timely and accurate updates to protocol management system at Guthrie and the data submission to the sponsor.
Guthrie’s updates include patient protocol enrollments, document submissions to IRB, and event management of patient follow-up visits. Submit research data to sponsor via the appropriate sponsor case report form submission process after review for accuracy and validation of information is obtained. Maintain study enrollment records from screening to study closure.
Contribute to the Clinical Research Department team. Support activities of others on the team. Provide cross coverage of research protocols as needed to support the total research department.
Other Duties: Collaborate with executive director, manager, research team members and IRB coordinator in developing and revising process flow for research procedures. Attend training seminars and conferences as required by sponsor of research study. Make presentations of study information to groups of physicians and patients.
Assist physicians in protocol development. Advise department manager on resource utilization and training needs. It is understood that this description is not intended to be all-inclusive and that other duties may be assigned as necessary in the performance of this position. #LI-RB1