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

Arizona Liver Health•Peoria, AZ

5d•Onsite

About The Position

Arizona Liver Health/Arizona Clinical Trials is hiring a full-time, non-exempt Clinical Research Coordinator II or III in Peoria, Arizona. Under the direction of a Principal Investigator or sub-investigator, the coordinator manages and implements assigned clinical research protocols in compliance with FDA regulations, Good Clinical Practice (GCP), company SOPs, and other applicable requirements. The role coordinates participant recruitment and screening, protocol activities and visits, data collection and documentation, study supplies and medication accountability, and participant education and support. The coordinator may take primary responsibility for implementing and managing new clinical trials and may oversee, train, and mentor support staff. The position also maintains accurate clinical trial management system records and source documentation; performs or assists with protocol-required clinical procedures and assessments; documents and reports adverse events; coordinates with investigators, staff, vendors, sponsors, and referral sources; and supports monitoring visits, audits, and regulatory inspections. The schedule is Monday through Friday, 7:00 a.m. to 4:00 p.m. Some interoffice travel may be required, using a company vehicle or mileage reimbursement. Compensation is $27.50 to $36 per hour, depending on experience.

Requirements

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

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 coordinate assigned protocols in compliance with FDA regulations, GCP, company SOPs, and other requirements.
Develop management systems and prepare for study initiation; review protocol requirements, inclusion and exclusion criteria, protocol summaries, and informed consent forms with the Principal Investigator.
Recruit and screen potential participants through chart and schedule reviews, outreach leads, and referrals, and work toward study recruitment goals.
Implement and manage new clinical trials when assigned.
Educate and support research subjects and families, serve as a consistent point of contact, and provide professional service to employees, subjects, physicians, vendors, and referral sources.
Maintain the clinical trial management system, including participant recruitment, visit completion, stipend tracking, and accurate patient status; assign stipend pay cards at screening and record screen-failure reasons in real time.
Collect, enter, review, correct, and transmit study data on time; follow electronic data access and security procedures and maintain source documentation for entered data.
Develop or edit source documents as needed, independently or with Quality Assurance/Quality Control, to ensure compliance with the protocol and electronic data capture requirements.
Obtain informed consent, medical histories, and medication lists; perform or assist with phlebotomy, basic laboratory tests, laboratory processing and shipping, ECGs, vital signs, questionnaires, assessments, efficacy assessments, and study drug administration, including injections.
Schedule patient visits and document visits and communications in progress notes and appropriate electronic systems.
Document and report adverse events and serious adverse events according to protocol; triage events and notify the research physician within 24 hours, then follow up with subjects and collaborate on needed information.
Maintain study supplies and medication accountability, track inventory, and reorder supplies as needed.
Perform administrative and regulatory filing, including subject participation records, laboratory results, receipts, invoices, and calibration reports; ensure subjects sign W-9 and medical release forms annually.
Manage site activities during audits and inspections, serve as a contact before, during, and after them, provide required documentation, coordinate responses to findings, and participate in sponsor monitoring visits.
Train and supervise assigned ancillary staff, train new research assistants and coordinators, and mentor externs.
Perform other responsibilities as delegated by the manager.