Research Coordinator - Clinical Research - FT

Socket.dev; Sayre (Bradford County); On-site; USD 45,000 - 65,000; Full time

Job summary

Guthrie Clinic once again seeks a dedicated Research Coordinator to advance clinical studies across outpatient and inpatient departments. The role includes coordinating visits, data management, and sponsor communications, with weekly travel between Sayre, PA and Binghamton, NY.

Strong knowledge of federal research regulations and GCP training is required. Responsibilities emphasize protocol adherence, participant screening and enrollment, and collaborative teamwork within the Clinical Research

Qualifications

• Experience with federal regulations related to clinical research.
• Training in Good Clinical Practice and human subjects protections.
• Proven study coordination experience and sponsor communications.

Responsibilities

• Coordinate projects by meeting sponsor training requirements and training staff.
• Coordinate participant visits, enrollments, and data collection per protocol.
• Update protocol management system and submit data to sponsor with accuracy.
• Support Clinical Research Department and provide cross coverage as needed.

Skills

GCP training

Study coordination

Regulatory knowledge

IRB/ethics familiarity

Education

Clinical Research Certification

AS- degree in applied science

BS degree + 1 year research exp

Job description

Research Coordinator - Clinical Research - FT

Summary:

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.

Experience:

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.

Education:

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.

Essential Functions:

1. 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.
2. 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.
3. 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.
4. 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:

1. Collaborate with executive director, manager, research team members and IRB coordinator in developing and revising process flow for research procedures.
2. Attend training seminars and conferences as required by sponsor of research study.
3. Make presentations of study information to groups of physicians and patients.
4. Assist physicians in protocol development.
5. Advise department manager on resource utilization and training needs.
6. It is understood that this description is not intended to be all-inclusive and that other duties may beassigned as necessary in the performance of this position.

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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.