Clinical Research Coordinator II or III (CRC 2-3) AMP

Arizona Liver Health•Chandler, AZ

25d•Onsite

About The Position

Arizona Liver Health/Arizona Clinical Trials is hiring a full-time, non-exempt Clinical Research Coordinator II or III in Chandler. Under the direction of a Principal Investigator or sub-investigator, the coordinator manages clinical research activities and implements assigned protocols in compliance with FDA CFR, GCP, company SOPs, and applicable regulatory, accreditation, and professional requirements. The role coordinates participant recruitment and screening, study visits and assessments, clinical data collection and documentation, study supplies and medication accountability, and communication with patients, families, physicians, sponsors, vendors, and regulatory representatives. The coordinator may take primary responsibility for implementing and managing new clinical trials and may train or supervise support staff, including CRC I staff and externs. The position also supports audits, inspections, monitoring visits, and follow-up on findings.

Requirements

At least two years of experience working as a Clinical Research Coordinator on late-phase clinical trials.
Associate or bachelor's degree in healthcare, clinical research management, or a related field.
GCP certification required at hire.
Experience and training in clinical research, including IRB submissions, reporting, source documentation, and trial management.
Thorough understanding of regulatory requirements, GCP principles, and biomedical research ethics.
Knowledge of regulatory requirements associated with assigned studies and an in-depth understanding of assigned protocols, protocol deviations, serious adverse events, and other reporting requirements.
Interpersonal and communication skills to interact effectively with professional and administrative staff, sponsors, regulators, patients, potential subjects, and referral sources.
Ability to perform all duties listed in the Phlebotomist job description.
Basic knowledge of medical terminology.
Experience with clinical research recruitment, including IRB submissions and trial enrollment management.
Experience with data management and tracking software.

Nice To Haves

Master’s degree.
Study-specific training.

Responsibilities

Manage clinical research activities under the direction of the Principal Investigator or sub-investigator and implement assigned protocols in accordance with FDA CFR, GCP, company SOPs, and applicable requirements.
Develop management systems and prepare for study initiation; review protocol requirements, inclusion and exclusion criteria, protocol summary sheets, and informed consent forms with the Principal Investigator.
Recruit and screen potential participants through chart and schedule reviews, outreach leads, and referrals; meet study recruitment goals and document screen-failure reasons in real time.
Educate and support participants and families, serving as a consistent contact and providing a professional service experience.
Coordinate and document informed consent, medical histories, medication lists, vital signs, ECGs, questionnaires, assessments, phlebotomy, basic laboratory tests, and efficacy assessments as required by protocol.
Process and ship laboratory samples to central and local laboratories; administer study drugs, including injections, when required by protocol.
Collect, record, review, correct, and submit study data; maintain source documentation and clinical trial management system records, resolve queries, and follow electronic data access and security procedures.
Schedule participant visits, document visits and communications in progress notes, track visits and participant and investigator stipends, assign patient stipend payment cards at screening, and maintain accurate participant status records.
Document, monitor, report, and triage adverse events and serious adverse events; communicate occurrences to the research physician within 24 hours and follow up with subjects as needed.
Maintain study files, supplies, medication accountability, and inventory; reorder supplies when necessary and perform administrative filing of research, regulatory, laboratory, financial, and calibration documents.
Ensure participants sign W-9 and medical release forms annually.
Manage site activities during audits and inspections, prepare required documentation, act as the site contact, coordinate responses to findings, and participate in sponsor monitoring visits.
Train and supervise assigned support staff, mentor externs, and train newly hired Research Assistants and/or CRCs.
Serve as a liaison to physicians, employees, third-party vendors, sponsors, regulatory representatives, participants, and referral sources.
Perform other responsibilities as delegated by the manager.
Travel between offices when required, using a company vehicle or mileage reimbursement.