Schedule Weekly Hours:

The Clinical Research Coordinator (CRC) provides research coordination and support to the principal investigators, patients, and Gundersen Health System staff for projects that support the mission and objectives of Gundersen Medical Foundation. The CRC meets the expectations of a professional employee.

Major Responsibilities:

1. Collaborates with investigators to recruit eligible subjects to clinical protocols.

2. Facilitates and oversees research studies by preparing regulatory documents for submission to Research Committee and the Institutional Review Board (IRB), managing data collection and developing and maintaining databases for the submission of protocol forms and treatment information to the Institutional Review Board. Identifies strategies to prevent protocol violations and is responsible for adverse event management and study closeout.

3. Screen, enroll, recruit, and obtain consent from research participants.

4. Responsible for overall coordination of research studies, including but not limited to, contracts, budgets, billing, monitoring, audits, mailing, lab kits, and submission of patient information.

5. Monitors treatment implemented by Physician or RN-CRC for protocol compliance and occurrence of adverse events. Identifies and implements strategies to prevent protocol violations.

6. Perform administrative and regulatory duties related to the study as appropriate.

7. Provides education/training for others within the department.

8. Obtains and maintains certification, via testing for:

• Clinical Research Coordinator Human Participants Protection Education for Research Teams and good clinical practice training

• Handling Shipping of Hazardous Materials, Infectious Substances and other Biologic Materials in compliance with the DOT and the Code of Federal Regulations.

9. Participates in the contract research organization's investigator meeting to become knowledgeable about the scientific, medical, and administrative aspects of the protocol, and attends meetings with specified research groups or sponsors. Some travel required.

10. Teams with the RN-CRC to facilitate the scheduling of tests and procedures for subjects participating in clinical trials according to protocol design, as well as facilitate/perform patient and family understanding of the protocol and informed consent as determined by scope of study.

11. Facilitates the collection, processing, and submission of specimens (e.g. blood/serum, pathology slides) to the appropriate location per protocol requirements.

12. Responsible for ordering and disposal of investigational drugs and maintaining accurate drug accountability logs per protocol specifications.

13. Downloads Radiology imaging to the study specific location.

14. Conducts each clinical trial using knowledge of research guidelines and regulations in accordance with the Code of Federal Regulations, Good Clinical Practice, Gundersen Lutheran Institutional Review Board, HIPAA, and Gundersen Lutheran policies and procedures. Maintains up-to-date knowledge of clinical research as it relates to medical practices and Federal Regulations.

15. Performs other job related responsibilities as requested.

Education and Learning:

REQUIRED

Bachelor's degree in Clinical Research Coordination or a related field

Work Experience:

REQUIRED

2 years of experience in a health care setting.

DESIRED

2 years of experience in a health care setting with research experience.

License and Certifications:

REQUIRED

Valid Driver's License (DL)

DESIRED

Current Infant-Adult Basic Life Support for Health Care Providers (with hands on learning) from one of the following programs; American Heart Association or American Red Cross.

Clinical Research Professional certification (CCRP) issued by the Society of Clinical Research Associates or Clinical Research Coordinator certification (CCRC) issued by the Association of Clinical Research Professionals

Age Specific Population Served:

Infant (less than 1 year)

Pediatric (1 - 12 years)

Adult (18 - 64 years)

Geriatric (65 years & older)

OSHA Category:

Category I - All Employees in this job title have a reasonably anticipated risk of occupational exposure to blood and/or other potentially infectious materials.

Environmental Conditions:

Exposed to infectious diseases.

Physical Requirements/Demands Of The Position:

Sitting Occasionally (6-33% or 3 hours)

Walking/Standing Frequently (34-66% or 5.5 hours)

Stooping/Bending Occasionally (6-33% or 3 hours)

Reaching - Shoulder Level Rarely (1-5% or .5 hours)

Reaching - Below Shoulder Frequently (34-66% or 5.5 hours)

Reaching - Above Shoulder Rarely (1-5% or .5 hours)

Repetitive Actions - Fine Manipulation Frequently (34-66% or 5.5 hours)

Lifting - Other Occasionally (6-33% or 3 hours) Number of lbs 25-50

Carrying - Short Carry Occasionally (6-33% or 3 hours) Number of lbs 25-50

If you need assistance with any portion of the application or have questions about the position, please contact HR-Recruitment@gundersenhealth.org or call 608-775-0267

Equal Opportunity Employer