Clinical Research Coordinator
About Us
AzLH is dedicated to driving high standards of care and advancing medical innovation through leading clinical trials, ensuring patient safety and regulatory compliance, and generating high-quality clinical data. Our network of multiphase, multitherapeutic research, standard of care, and VEN Centers sites is staffed by skilled providers, research, clinic, pharmacy, and patient outreach professionals. AzLH operates state-of-the-art facilities and programs to meet the evolving needs of clinical research and overall patient treatment.
Job Summary
AzLH/Arizona Clinical Trials is seeking qualified candidates for the Clinical Research Coordinator II or III position in Peoria. The position offers a competitive salary range of $27.50 to $36 per hour, full-time, non-exempt, hourly work schedule, and four openings available.
Essential Job Functions/Duties
- Manage the conduct of clinical research activities under the direction of the Principal Investigator or sub-investigator.
- Implement assigned protocols in compliance with FDA CFR, GCP, and company SOPs.
- Collect and record clinical research data, assist in patient assessments, schedule, maintain study files, study supplies, and study medication accountability.
- Develop management systems and prepare for study initiation.
- Review inclusion/exclusion criteria, overall structure, and requirements of each protocol.
- Review protocol summary sheets and Informed Consent Forms for accuracy and clarity.
- Recruit and screen potential participants, including chart review of patients and schedules, contacting leads from outside recruitment efforts, and following up on referrals from all sources.
- Meet recruitment goals for each study.
- Assume primary responsibility in the implementation and management of new clinical trials.
- Perform all functions according to established policies, procedures, regulatory, and accreditation requirements.
- Provide educational information to subjects and serve as a resource and support person for subjects and families.
- Provide an excellent service experience by consistently demonstrating professional decorum.
- Serve as a liaison to all physicians, employees, and third-party vendors.
- Record data and study documentation, keep the clinical trial management system updated, and assign patient stipend pay cards.
- Document reasons for screen-fail in real time, plan, prepare, and perform tasks required by protocol, and document all patient visits and communications in progress notes.
- Document and record all AEs and SAEs as outlined in protocol, monitor and report adverse events, triage adverse events, and communicate with the research physician regarding the occurrence of adverse and serious adverse events within 24 hours.
- Ensure W-9 and medical release forms are signed by subjects annually.
- Manage site activities during audits and inspections, manage ancillary staff as assigned, train and supervise support staff, mentor for externs, and prepare for quality assurance audits and regulatory inspections.
- Participate in monitoring visits from sponsor provided appointees, ensure monitors are able to meet/speak with PI, and address all concerns in a timely manner.
- Participate in other responsibilities as delegated by manager.
Knowledge/Skills/Abilities Required
- Minimum (2) years of experience working previously as a Clinical Research Coordinator for late phase clinical trials.
- Experience and training in the conduct of clinical research (specific experience and/or training in clinical research, including IRB submissions, reporting and source documentation, trial management).
- A thorough understanding of regulatory requirements, principles of GCP, and biomedical research ethics.
- Interpersonal and communication skills—interact effectively with professional, administrative staff, sponsor and regulatory representatives, patients, potential subjects, and referral sources.
- Possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility protocol deviations, serious adverse events, and other reporting requirements.
- Able to perform all Job duties listed for Job Description for Phlebotomist.
- Experience and training in the conduct of clinical research and basic knowledge of medical terminology.
- Experience and training in the conduct of clinical research (specific experience and/or training in clinical research recruitment, including IRB submissions and trial enrollment management).
- Experience with data management and tracking software.
Benefits & Perks
- Health, Dental, Vision (with HSA plans and employer contribution)
- 3 weeks of PTO
- 5 days Sick Time
- 401K with 6% company match
- Short & Long Term Disability
- CEUs / Educational Assistance
- Shared company vehicles for required travel
EEO Statement
It is the policy of the Institute for Liver Health DBA Arizona Liver Health and Arizona Clinical Trials to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law. This policy relates to all phases of employment, including, but not limited to, recruiting, employment, placement, promotion, transfer, demotion, reduction of workforce and termination, rates of pay or other forms of compensation, selection for training, the use of all facilities, and participation in all company-sponsored employee activities. Provisions in applicable laws providing for bona fide occupational qualifications, business necessity or age limitations will be adhered to by the company where appropriate.