Clinical Research Coordinator - RN

NOW HIRING!

Clinical Research Coordinator, RN

Great Lakes Gastro | Mentor, Ohio

Help Advance the Future of Gastroenterology Through Clinical Research!

Location: 8877 Mentor Avenue, Mentor, OH 44060

Position: Full-Time

Department: Clinical Research

License Required: Registered Nurse (RN)

Make a Difference Beyond the Bedside!

Are you a Registered Nurse looking for an exciting opportunity to combine your clinical expertise with innovative research? Do you enjoy patient education, hands-on nursing care, and being part of something that makes a difference in the future of medicine?

Great Lakes Gastro is looking for a Clinical Research Coordinator RN to join our growing team!

This is an exciting opportunity for a dedicated, detail-oriented nurse who wants to play an important role in advancing gastrointestinal healthcare through clinical research.

As a Clinical Research Coordinator, you will coordinate and administer clinical research studies, including industry-sponsored clinical drug trials, while ensuring patient safety, regulatory compliance, and exceptional patient care.

You will work closely with gastroenterologists, Principal Investigators, research sponsors, and clinical staff to facilitate clinical trials from start to finish.

Whether you have previous clinical research experience or are an experienced RN interested in expanding your nursing career into research, we'd love to hear from you!

What You'll Do

Clinical Research Coordination

• Coordinate and manage industry-sponsored clinical research trials from initiation through completion.
• Independently screen potential participants for clinical research studies.
• Perform detailed medical chart reviews and patient interviews to identify eligible participants.
• Review patient medical histories against study-specific inclusion and exclusion criteria.
• Coordinate patient research visits, procedures, and follow-up appointments according to study protocols.
• Collaborate with Principal Investigators, the Research Director, sponsors, and clinical staff.
• Assist with study start-up, implementation, and day-to-day research operations.

Hands-On Clinical Nursing Responsibilities

• Educate patients about clinical research participation, study requirements, and disease processes.
• Discuss study protocols with patients and verify completion of informed consent documentation.
• Perform IV starts, venipuncture, blood draws, and other protocol-required procedures.
• Collect vital signs and perform electrocardiograms (ECGs).
• Process, prepare, and ship blood, urine, and other laboratory specimens in accordance with study protocols and applicable IATA regulations.
• Dispense and manage investigational medications according to study protocols and regulatory requirements.
• Monitor research participants and communicate clinical findings and concerns to the appropriate medical staff.
• Triage patient phone calls, answer clinical questions within the scope of nursing practice, and recognize when escalation is necessary.

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Regulatory Compliance & Documentation

• Ensure adherence to research standard operating procedures (SOPs), Good Clinical Practice (GCP), FDA regulations, and Human Subject Protection (HSP) requirements.
• Maintain accurate and complete research documentation and regulatory records.
• Complete and maintain case report forms (CRFs), ensuring accuracy and consistency with patient medical records.
• Perform routine data verification and quality control to maintain research data integrity.
• Monitor study progress and assist with identifying and resolving protocol deviations and compliance concerns.
• Maintain patient confidentiality and adhere to infection control and safety guidelines.

Teamwork, Education & Communication

• Serve as a resource for clinical staff regarding research procedures and investigational guidelines.
• Develop educational materials and tools to support staff training and patient recruitment.
• Assist the Principal Investigator and Research Director with administrative research responsibilities.
• Coordinate research activities, staffing needs, and study-related resources.
• Prepare periodic reports and maintain records of research activities.
• Promote ethical research practices and high professional standards.

What We're Looking For

Required Qualifications

• Current, unrestricted Registered Nurse (RN) license.
• Clinical nursing experience.
• Strong organizational, communication, and time-management skills.
• Excellent clinical judgment, critical-thinking abilities, and attention to detail.
• Ability to work independently while collaborating effectively with a multidisciplinary team.
• Proficiency with electronic medical records and computer-based documentation.

Preferred Qualifications

• Previous clinical research or clinical trial coordination experience.
• Gastroenterology, hepatology, infusion, or outpatient nursing experience.
• Knowledge of FDA regulations, GCP guidelines, and human subject protection requirements.
• Experience with phlebotomy, IV insertion, and ECGs.
• Current GCP certification or willingness to obtain certification.

We're especially interested in nurses who are enthusiastic about learning, patient-centered, organized, and passionate about advancing healthcare through research!

AWESOME PERKS, JUST FOR YOU!

At Great Lakes Gastro, we believe in investing in our employees and supporting their personal and professional success. We offer a competitive benefits package designed to help you thrive both at work and beyond!

• Generous Paid Time Off: Enjoy excellent PTO to support a healthy work/life balance.
• 401(k) with Employer Match: We have your future in mind! Build your retirement savings with our generous 401(k) plan and employer matching contributions.
• Education Reimbursement: Looking to further your education or expand your clinical skills? We offer annual education reimbursement opportunities based on employment status.
• Professional Growth & Development: We support internal advancement opportunities, ongoing training, and professional development to help you grow your career.
• Competitive Health & Supplemental Benefits: Enjoy a variety of health and supplemental benefit options, including Flexible Spending Accounts (FSA) and Health Savings Accounts (HSA), where eligible.
• Employee Referral Bonus Program: Love where you work? Spread the word! Refer a friend who would be a great addition to our team and earn a special bonus when they join us!