Research Coordinator - Clinical Research

Guthrie Enterprise•Sayre, PA

12h•Hybrid

About The Position

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.

Requirements

Knowledge of federal regulations related to research
Documented experience with study coordination
Documented training of Good Clinical Practice research standards training
Completion of CITI Basic Research course regarding Human Subject’s Protection Training within one month of employment
Five years’ experience in a Clinical Research office with certification as a Clinical Research Professional
Associate Degree in applied science with five years’ experience in the medical field
Bachelor of Science degree with one-year experience in a research facility/hospital setting

Responsibilities

Coordinate specific projects, which includes 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, including screening, enrolling, organizing patient visits to meet study requirements at specific protocol timelines, performing patient interviews related study assessments, dispensing prescribed study medication, determining medication compliance, and following 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 by supporting activities of others on the team and providing cross coverage of research protocols as needed to support the total research department.
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.