Clinical Research Coordinator II (CRC2) Tucson

Arizona Liver Health (ALH) 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. ALH operates state-of-the-art facilities and programs to meet the evolving needs of clinical research and overall patient treatment.

About the role

We are looking for qualified candidates for the Clinical Research Coordinator II position in Tucson, AZ. This is a full-time, non-exempt role with a schedule of Monday-Friday, 7am-4pm.

Responsibilities

• Under the direction of the Principal Investigator or sub-investigator, manage the conduct of clinical research activities.
• Coordinate and implement assigned protocols in compliance with FDA CFR, GCP, and company SOPs.
• Collect and record clinical research data, assist in patient assessments, scheduling, maintain study files, study supplies, and study medication accountability.
• Develop management systems and prepare for study initiation.
• Review with the Principal Investigator the inclusion/exclusion criteria, overall structure, and requirements of each protocol.
• Review the protocol summary sheet and the Informed Consent Form for accuracy and clarity to communicate these protocols to staff and patients.
• Recruit and screen potential participants, including chart review of patients, scheduling, contacting leads from outside recruitment efforts, and following up on referrals.
• 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 (SOPs), procedures, regulatory, and accreditation requirements.
• Provide educational information to subjects and serve as a resource and support person for subjects and families.
• Act as a liaison to physicians, employees, and third-party vendors.
• Keep the clinical trial management system updated with newly recruited subjects, tracking completed visits, and stipends for participants and investigators.
• Assign patient stipend pay card at screening and document reason for screen-fail in real time.
• Plan, prepare, and perform tasks required by protocol, including but not limited to:
  • Record data using the appropriate media or platform.
  • Follow procedures for access and security for electronic data entry.
  • Review keyed data for accuracy.
  • Send data to the data collection center on a timely basis.
  • Maintain source documentation for all data entered.
  • Develop and/or edit source documents to ensure compliance with protocol and EDC.
  • Correct and edit data as directed.
• Obtain patient medical history and medication lists.
• Perform phlebotomy and basic laboratory tests.
• Process and ship labs for central and local labs.
• Provide patient education and training.
• Administer ECGs, questionnaires, and assessments.
• Collect vital signs and information for adverse event reporting.
• Assist with efficacy assessments.
• Administer study drugs, including injections, and track study supply inventory.
• Schedule patient visits in appropriate electronic systems.
• Document all patient visits and communications in progress notes.
• Record and report all adverse events (AEs) and serious adverse events (SAEs) as outlined in the protocol.
• Triage adverse events and communicate with the research physician regarding AEs and SAEs within 24 hours.
• Handle administrative duties including filing documents related to subject participation, regulatory, lab results, receipts, invoices, and calibration reports.
• Ensure W-9 and medical release forms are signed by subjects annually.
• Manage site activities during audits and inspections.
• Train and supervise support staff (e.g., CRC I) and mentor externs.
• Train newly hired employees as Research Assistants and/or CRCs.
• Prepare for quality assurance audits and regulatory inspections.
• Act as the contact person before, during, and after audits and inspections.
• Provide all required documentation to auditors and make appropriate corrections as requested.
• Coordinate site response to audit/inspection findings.
• Participate in monitoring visits from sponsor-appointed representatives, ensuring monitors can meet/speak with the PI and addressing all concerns in a timely manner.
• Perform other responsibilities as delegated by the manager.

Requirements

• Minimum of 2 years of experience working as a Clinical Research Coordinator for late-phase clinical trials.
• Experience and training in the conduct of clinical research, including IRB submissions, reporting, source documentation, and trial management.
• A thorough understanding of regulatory requirements, principles of GCP, and biomedical research ethics.
• Strong interpersonal and communication skills to interact effectively with professional and administrative staff, sponsors, regulatory representatives, patients, and referral sources.
• Sound understanding of each assigned protocol, including protocol deviations, serious adverse events, and other reporting requirements.
• Ability to perform all job duties listed for the Phlebotomist role.
• Knowledge of all regulatory requirements associated with the conduct of assigned studies.
• Some interoffice travel may be required with the use of a company vehicle or mileage reimbursement.

Qualifications

• Associate's or Bachelor's degree in healthcare, clinical research management, or a related field required; Master’s degree or study-specific training preferred.
• GCP certification required at hire.
• Experience and training in clinical research and basic knowledge of medical terminology.
• Experience with data management and tracking software.

Pay

$27.50 to $33.00 per hour, depending on experience.

Benefits

• Health, Dental, and Vision insurance (with HSA plans and employer contribution).
• 3 weeks of PTO.
• 5 days of sick time.
• 401K with 6% company match.
• Short & Long Term Disability.
• CEUs / Educational Assistance.
• Shared company vehicles for required travel.