Clinical Research Manager jobs in Louisville, KY

Job Details

Have you been looking for a place to grow your skillset? Or perhaps you are looking for a place to develop your career surrounded by a diverse group where employees feel a sense of belonging.

At Gastroenterology Health Partners we are championing the power of inclusivity and a people first mentality. We hope to improve the human experience – from our patients to our colleagues.

If you are interested in joining our culture, we’re looking for a Clinical Research Coordinator.

A little about us:

Gastroenterology Health Partners is a team of gastroenterologists and allied health professionals with a proven track record of providing excellent care that families can count on. We specialize in treating the full range of digestive diseases and endeavor to provide exceptional care, for every patient, every time.

We are powered by One GI®, a true collaboration of the very best clinical and business minds – which enables us to focus on what’s truly important – our patients.

Snapshot of Daily Duties: 

Location: 1941 Bishop Lane Louisville, KY 

• Administratively and clinically manage industry sponsored clinical trials.
• Assist in patient recruitment by performing detailed chart reviews and patient interviews
• Discuss study protocols with patients and verify the informed consent documentation.
• Review medical history of patient against inclusion/exclusion criteria of studies.
• Perform blood draws, process and ship blood/urine specimens per study protocol and IATA regulations.
• Schedule all patient research visits and procedures consistent with protocol requirements
• Dispense study medication, collect vital signs, and perform ECGs.
• Complete and maintain case report forms per FDA guidelines and review them against the patient’s medical record for completeness and accuracy.
• Monitor patients and providing information to the medical staff and other staff members to assure optimal outcomes.
• Responsible for the education of patients in all aspects of the disease process and/or clinical study in which the patient may be involved.
• Assist the principal investigator and research director with various administrative tasks associated with the day-to-day operations of research studies and projects.
• Facilitate assigned clinical trial from start to finish.

The Must Haves

• Associate Degree in a clinical or scientific related discipline required. Bachelor's degree preferred.
• One (1) year previous experience as a clinical research coordinator for pharmaceutical phase II or III trials required.
• Previous GI trials experience preferred. Previous Research experience or equivalent experience preferred
• Clinical experience in an office or hospital setting.
• BLS certified.
• Understanding of Code of Federal Regulations for Human Subjects.
• Certified in GCP’s and HSP.
• Phlebotomy experience preferred.
• Willing to travel to New Albany location for studies. 

The Perks

• 401k with match
• Tuition reimbursement
• The best swag with the coolest logo…OG
• Excellent paid time off for balance of work/life
• Internal growth opportunities with training and development
• Competitive health & supplemental benefits
• Impact somebody’s life and make a difference