Job Description
Job Description Position Summary: Coordinate multiple in-patient and out-patient clinical research protocols.
Education/Experience: Required : An Associate’s degree in applied science or five years’ experience in a medical office, research facility or hospital setting may be equivalent. Knowledge of federal regulation related to research, documented experience with study coordination, and documented training of good clinical research standards training preferred. The completion of the CITI Basic Research course regarding Human Subjects Protection Training is required within one month of employment. Certification as a research professional within three years in the position is required.
Desired : A Bachelor of Science degree is preferred with 2 years’ experience in a medical office, research facility or hospital setting.
Essential Functions :
- Collaborate with the manager and director for the development of department research programs. This is demonstrated through coordination of specific research projects in multiple disease conditions. Responsibilities for program development include assisting with feasibility, site selection, IRB document review, and corresponding with investigators, IRB, and sponsors
- 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
- Perform other duties as assigned by the executive director or manager
About Us Joining the Guthrie team allows you to become a part of a tradition of excellence in health care. In all areas and at all levels of Guthrie, you’ll find staff members who have committed themselves to serving the community.
The Guthrie Clinic is an Equal Opportunity Employer.
The Guthrie Clinic is a non-profit, integrated, practicing physician-led organization in the Twin Tiers of New York and Pennsylvania. Our multi-specialty group practice of more than 500 physicians and 302 advanced practice providers offers 47 specialties through a regional office network providing primary and specialty care in 22 communities. Guthrie Medical Education Programs include General Surgery, Internal Medicine, Emergency Medicine, Family Medicine, Anesthesiology and Orthopedic Surgery Residency, as well as Cardiovascular, Gastroenterology and Pulmonary Critical Care Fellowship programs. Guthrie is also a clinical campus for the Geisinger Commonwealth School of Medicine.
Job Tags
Full time, Work at office,