Phase 1 Clinical Research Coordinator (Full-time, Tue-Thu, 7PM-7AM)

Arizona Liver Health • Chandler, AZ

2d • Onsite

About The Position

Arizona Liver Health is hiring a Phase 1 Clinical Research Coordinator to coordinate and conduct clinical research activities under the direction of a Principal Investigator or sub-investigator. The role supports participant engagement, enrollment, retention, protocol implementation, patient safety, regulatory compliance, and high-quality clinical data collection. The position is based in a clinic setting and works an overnight schedule, Tuesday through Thursday, from 7:00 PM to 7:00 AM.

The coordinator implements assigned protocols in compliance with FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures. Duties include screening and enrolling subjects; coordinating visits and study procedures; maintaining study files, supplies, medication accountability, and accurate clinical trial management system records; documenting data and adverse events; and supporting study initiation, audits, and regulatory inspections. After appropriate training and delegation, the coordinator performs study procedures required during the shift and prepares for the next shift, including nursing and protocol-specific procedures.

The position also involves monitoring participant status and compliance, responding to subject needs, communicating changes or concerns to investigators, and maintaining a safe and orderly clinic environment. The role requires an active Arizona RN license or a multistate license with Arizona practice privileges, current BLS and ACLS certifications, and at least one year of professional nursing experience. Phase 1 clinical research experience is preferred.

Requirements

• Associate Degree in Nursing (ADN) from an accredited nursing program.
• Current, unrestricted Registered Nurse license issued by the Arizona State Board of Nursing, or a current multistate RN license with privilege to practice in Arizona.
• Current Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) certifications.
• At least one year of professional nursing experience in a clinic, hospital, acute care, outpatient, or clinical research setting.
• Completion of Good Clinical Practice (GCP), human-subject protection, and study-specific training within required company timelines.
• Competency in venipuncture, intravenous access, medication administration, and other protocol-required nursing procedures.
• Training appropriate to anticipated duties, such as medical assistant, associate, undergraduate, or graduate education or equivalent, study-specific training, or other applicable training.
• Experience and training in clinical research, including relevant experience or training with IRB submissions, reporting, source documentation, and trial management.
• Thorough understanding of regulatory requirements, GCP principles, and biomedical research ethics.
• Interpersonal and communication skills to interact effectively with professional and administrative staff, sponsor and regulatory representatives, patients, potential subjects, and referral sources.
• Valid documentation and authorization to work in the U.S.; visa sponsorship or visa transfer is not offered.
• Ability to lift at least 30 pounds.
• Ability to sit for long periods, at least 50% of the time.
• Ability to type and perform computer work for long periods.

Nice To Haves

• Bachelor of Science in Nursing (BSN).
• Experience in Phase 1 clinical research.
• Additional research or specialty certifications.

Responsibilities

• Develop and implement strategies to achieve site goals for participant engagement, enrollment, and retention.
• Build and maintain relationships with clinical teams and other facility stakeholders.
• Identify barriers to enrollment and retention, monitor them, and develop solutions.
• Assist with training new staff and support the site manager as needed.
• Assess and evaluate local strategies to determine whether they are successful.
• Manage clinical research activities under the direction of the Principal Investigator or sub-investigator.
• Coordinate and implement assigned protocols in compliance with FDA regulations, GCP, and company SOPs.
• Assist with implementing and managing new clinical trials.
• Collect and record clinical research data; assist with patient assessments and scheduling; maintain study files, supplies, and study medication accountability.
• Update the clinical trial management system with recruited subjects, completed visits, stipends, and accurate patient status.
• Develop management systems and prepare for study initiation.
• Conduct and document study-required procedures within protocol-specific guidelines and timelines, including real-time documentation and handoff of wet-ink documents to oncoming staff.
• Record study data and documentation using the required media or platform, and follow electronic data access and security procedures.
• After appropriate training and delegation, perform study-related procedures required during the shift and in preparation for the next shift. Procedures may include ECGs, vital signs, medication administration, questionnaires, IV access, blood draws and processing, urine collection, intake and output tracking, and collection and processing of bodily secretions.
• Answer phone calls and direct them appropriately.
• Order subject meals and ensure subjects eat according to protocol requirements; ensure subject and staff meals follow company guidelines.
• Manage study activities, subject compliance, and documentation.
• Screen and enroll study subjects.
• Document adverse events according to protocol and promptly notify the investigator or clinical coordinator of potential adverse reactions.
• Manage site activities during audits and inspections; prepare for quality assurance audits and regulatory inspections and act as a contact person before, during, and after them.
• Check bags of subjects checking into the unit for prohibited items and secure any items found.
• Perform duties according to established policies, procedures, regulatory requirements, and applicable professional standards.
• Maintain BLS/ACLS training according to company policy; call 911 in an emergency and immediately notify the investigator.
• Notify the investigator or delegated staff of changes in subject status or subject complaints.
• Administer over-the-counter medication under the investigator’s direction.
• Assist subjects with hygiene needs, keep rooms clean, and change bed linens as needed.
• Accompany subjects on walks outside and attend during smoking breaks.
• Maintain stocks of snacks, sodas, water, and other supplies; order supplies or provide a list of needed items to Phase 1 staff.
• Keep drawers and closets stocked with needed supplies.

Benefits

• Health, dental, and vision coverage, including HSA plans with employer contribution.
• Paid time off.
• Five days of sick time.
• Seven company holidays and two half-days.
• 401(k) with up to 6% company match.
• Short- and long-term disability coverage.
• Educational assistance.
• Shared company vehicles for required travel.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree