Position Summary

We are seeking an experienced Clinical Research Coordinator/Nurse to support the execution of interventional clinical trials within an academic medical center, hospital, or healthcare research environment. This individual will work closely with Principal Investigators, clinical teams, research operations, and study sponsors to coordinate day-to-day study activities and ensure trials are conducted in accordance with the protocol, Good Clinical Practice (GCP), and applicable regulatory requirements.

The level of support may vary throughout the study lifecycle. Some weeks may require heavier onsite activity based on participant visits, study startup, enrollment, or data deadlines, while other periods may require fewer hours. The coordinator may support one or more studies and will be responsible for accurately tracking time by study.

Key Responsibilities
• Coordinate daily clinical trial activities from study startup through closeout.
• Work directly with Principal Investigators and study teams to execute protocol-required activities.
• Review study protocols, schedules of events, and study manuals to understand visit requirements and operational needs.
• Support participant identification and recruitment through clinic referrals, electronic health record review, patient lists, and other approved recruitment methods.
• Conduct or support participant pre-screening and screening activities.
• Coordinate participant visits, study procedures, follow-up activities, and required assessments.
• Obtain and document informed consent when permitted by protocol, institutional policy, and individual qualifications.
• Administer, deliver, or coordinate investigational products and study medications when permitted by licensure, protocol requirements, and institutional policy.
• Perform or coordinate phlebotomy, specimen collection, processing, shipping, and other protocol-specific procedures as required.
• Prepare participant charts and study materials prior to visits.
• Maintain accurate source documentation and study records.
• Enter and maintain study data in electronic data capture (EDC) systems and other research platforms.
• Respond to data queries and support timely data reconciliation.
• Track participant status, study visits, deviations, adverse events, and outstanding action items.
• Maintain regulatory documentation and essential study files.
• Collaborate with pharmacy, laboratory, nursing, regulatory, finance, and other cross-functional teams.
• Complete required sponsor, institutional, and protocol-specific training.
• Accurately document time worked and allocate hours to the appropriate study or project.
• Maintain participant confidentiality and comply with HIPAA, GCP, and all applicable regulatory standards.

Required Qualifications
• Bachelor's degree in Nursing, Life Sciences, Healthcare, or a related field, or an equivalent combination of education and clinical research experience.
• Prior experience supporting clinical research studies in a hospital, academic medical center, clinic, or similar research environment.
• Experience coordinating interventional clinical trials.
• Working knowledge of Good Clinical Practice (GCP), informed consent requirements, source documentation, and research compliance.
• Experience working with Principal Investigators, clinical staff, sponsors, and cross-functional research teams.
• Ability to independently manage study activities and prioritize work across changing study demands.
• Strong attention to detail, organization, documentation, and communication skills.
• Proficiency with electronic health records, electronic data capture systems, and Microsoft Office applications.
• Ability to work onsite as required by participant visits and study activities.

Preferred Qualifications
• Active Registered Nurse (RN) license, particularly for studies involving medication administration or other licensed clinical procedures.
• Phlebotomy experience.
• Experience with investigational product administration, medication delivery, PK sampling, timed blood draws, or other protocol-driven clinical procedures.
• Experience supporting endocrinology, oncology, internal medicine, or other complex therapeutic-area studies.
• Experience with Epic, REDCap, or other electronic data capture systems.
• ACRP or SOCRA certification.