Clinical Research Coordinator

Nucleus Network conducts early-phase clinical trials for commercial sponsors, with a specialised focus on Phase I studies involving healthy volunteers and patient populations. The Minneapolis (MSP) site supports the delivery of high-quality clinical research in accordance with U.S. regulatory requirements, ethical standards, and Nucleus Network global SOPs.

The Clinical Research Coordinator (CRC) is a specialized research professional responsible for the operational delivery of assigned clinical trials. The CRC acts as the primary, on-site coordinator for day-to-day study activities and serves as a key liaison between study participants, investigators, sponsors, and internal teams. The role supports studies from initial submission through to close-out and archiving, ensuring compliance with protocols, GCP, and applicable U.S. regulations.

Key Responsibilities

Study Coordination & Delivery

• Coordinate and support the conduct of assigned clinical trials from start-up through close-out, including study set-up, participant visits, and study documentation.
• Act as the primary point of contact for study participants, ensuring a high-quality participant experience and adherence to study schedules.
• Support investigator and sponsor interactions, including site visits, monitoring visits, and audits.

Participant Management

• Coordinate participant screening, enrolment, consent, study visits, follow-up, and study completion activities.
• Ensure participant safety through accurate documentation, adverse event reporting, and escalation of safety concerns in line with protocol and SOPs.

Regulatory & Compliance

• Ensure studies are conducted in accordance with FDA regulations, ICH-GCP, IRB approvals, study protocols, and Nucleus Network SOPs.
• Assist with preparation and maintenance of essential documents, including Investigator Site Files (ISF) and source documentation.
• Support IRB submissions, amendments, continuing reviews, and study close-out documentation as required.

Data & Documentation

• Complete accurate, timely, and high-quality clinical documentation in source documents, electronic systems, and study files.
• Perform quality control checks of pre-study, on-study, and post-study documentation.

Collaboration & Communication

• Work closely with Principal Investigators, Project Managers, Senior CRCs, Nursing, Pharmacy, and Laboratory teams to ensure seamless study delivery.
• Participate in study meetings, training sessions, and site initiatives as required.

Mandatory Requirements

• Bachelor’s degree in a health, science, or related discipline (or equivalent experience).
• Eligibility to work in the United States.
• Completion of GCP training and ongoing compliance with mandatory training requirements.

Skills & Experience

• Previous experience in a Clinical Research Coordinator or equivalent clinical research role, preferably in a Phase I or early-phase environment.
• Strong understanding of clinical research practices, ethical obligations, and ICH-GCP guidelines.
• Excellent organisational skills with the ability to manage multiple priorities in a fast-paced environment.
• High attention to detail and commitment to data quality and participant safety.
• Strong interpersonal and communication skills (verbal and written).
• Proficiency in Microsoft Office and clinical trial management systems.
• Experience working within U.S. FDA-regulated clinical trial environments.
• Exposure to electronic data capture (EDC) systems and IRB processes.
• Experience working with healthy volunteer Phase I studies.

This Job Description Form outlines the general nature and level of work performed by employees assigned to this position. It is not intended to be an exhaustive list of all responsibilities, duties, and skills required

For further information about Nucleus Network, please go to www.nucleusnetwork.com

Job Type: Full-time

Pay: $50,000.00 - $65,000.00 per year

Work Location: In person