Clinical Research Coordinator
Location: Omaha, Nebraska
Employment Type: Full-Time
About Us
We are a growing clinical research site dedicated to advancing medicine through high-quality clinical trials. Our team partners with sponsors, physicians, and study participants to bring innovative therapies to patients while maintaining the highest standards of patient care, regulatory compliance, and research excellence.
Position Summary
The Clinical Research Coordinator (CRC) is responsible for the day-to-day management and coordination of clinical research studies under the direction of the Principal Investigator (PI). The CRC serves as the primary liaison between study participants, sponsors, CROs, and research staff to ensure studies are conducted in compliance with protocol requirements, Good Clinical Practice (GCP), FDA regulations, and site policies.
Candidates must be comfortable performing routine phlebotomy and specimen processing as an essential function of this role.
Key Responsibilities
- Coordinate all aspects of assigned clinical trials from study start-up through study closeout.
- Recruit, screen, consent, and enroll study participants according to protocol requirements.
- Conduct and document the informed consent process.
- Schedule and manage participant visits, procedures, and follow-up activities.
- Perform phlebotomy and process laboratory specimens according to protocol requirements and site procedures.
- Collect, package, ship, and track laboratory specimens in accordance with sponsor and laboratory guidelines.
- Collect, enter, and maintain accurate study data and source documentation.
- Monitor participant safety and promptly report adverse events, serious adverse events, and protocol deviations.
- Maintain regulatory binders, study files, and Institutional Review Board (IRB) documentation.
- Communicate effectively with sponsors, CROs, monitors, laboratories, investigators, and study participants.
- Prepare for sponsor monitoring visits, audits, and regulatory inspections.
- Ensure compliance with FDA regulations, ICH-GCP guidelines, HIPAA requirements, and study protocols.
- Assist with study start-up activities, feasibility assessments, and participant retention efforts.
- Support a positive participant experience while maintaining confidentiality and professionalism.
Qualifications Required
- Minimum of 1 year of clinical research, healthcare, or related experience preferred.
- Demonstrated phlebotomy experience and proficiency in venipuncture.
- Ability to collect, process, package, and ship laboratory specimens according to protocol and laboratory requirements.
- Strong organizational, communication, and problem-solving skills.
- Ability to manage multiple studies and priorities simultaneously in a fast-paced environment.
- Proficiency with Microsoft Office applications and electronic data systems.
- Ability to work independently while collaborating effectively with investigators and study staff.
- Reliable transportation and ability to work on-site in Omaha, Nebraska.
Preferred
- Previous experience coordinating clinical trials.
- Knowledge of FDA regulations, ICH-GCP guidelines, HIPAA requirements, and human subject protections.
- Experience with Electronic Data Capture (EDC) systems, CTMS platforms, and electronic regulatory systems.
- Current phlebotomy certification, Medical Assistant certification, LPN, RN, or other healthcare credentials.
- ACRP (CCRC) or SOCRA (CCRP) certification, or willingness to obtain certification.
What We Offer
- Competitive salary based on experience.
- Comprehensive benefits package.
- Opportunities for professional growth and clinical research certification support.
- Collaborative, patient-focused work environment.
- The opportunity to contribute to innovative research that advances healthcare and improves patient outcomes.
How to Apply
Interested candidates should submit a resume and cover letter outlining their experience and interest in clinical research.
Join our team and help bring tomorrow’s treatments to patients today
Pay: $25.33 - $35.00 per hour
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Health savings account
- Vision insurance
Work Location: In person
