Clinical Research Coordinator II/III (Phase I)

About Us

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.

Responsibilities

• Develop and implement strategies to achieve Site Goals for participant engagement, enrollment, and retention.
• Build and maintain relationships with clinical teams and other stakeholders at your facility.
• Identify and monitor barriers to enrollment and retention and develop solutions to overcome them.
• Assist with training new staff members and assisting the site manager as needed.
• Ensure local strategies are successful through regular assessment and evaluations.
• 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.
• Assume responsibility in the implementation and management of new clinical trials in a knowledgeable and collaborative manner.
• Collect and record clinical research data, assist in patient assessments, scheduling, maintain study files, study supplies, and study medication accountability.
• Keep the clinical trial management system updated with newly recruited subjects, tracking completed visits and stipends for participants and investigators, ensuring the status of each patient is accurate.
• Develop management systems and prepare for study initiation.
• Conduct study-required procedures within study-specific guidelines/timeline and document in real time.
• Record data and study documentation, ensuring all “wet ink” documents are filed appropriately.
• Perform all study-related procedures required on shift, including ECGs, vital signs, administering investigational product (IP), questionnaires, starting IVs, drawing and processing blood, urine collection, and managing intake/output sheets.
• Answer phone calls and direct appropriately.
• Order subject meals and ensure they eat per protocol requirements; manage study-related activities, subject compliance, and documentation.
• Screen and enroll study subjects.
• Document all adverse events as required per protocol and notify the investigator or clinical coordinator of any potential adverse reactions.
• Manage site activities during audits and inspections; prepare for quality assurance audits and regulatory inspections.
• Act as contact person before, during, and after audits and inspections.
• Ensure all subject bags are checked for prohibited items (e.g., cigarettes, lighters, pocket knives, home meds) and secure them if found.
• Perform duties according to established policies, procedures, regulatory requirements, and professional standards.
• Administer over-the-counter medication under the direction of the investigator.
• Assist subjects with hygiene needs, keep rooms clean, and change bed linen as needed.
• Take subjects on walks outside and attend during smoking breaks.
• Keep stock of snacks, sodas, water, and other supplies; maintain drawers and closets with needed supplies.
• Training in BLS/ACLS per company policy; call 911 in emergency situations and notify the investigator immediately.
• Notify investigator or delegated staff of any changes in subject status or complaints.

Requirements

• High School Diploma or GED required; Bachelor’s degree preferred.
• BLS and ACLS training required.
• 0-3 years of experience in the field or a related area.
• Medical Assistant certification or diploma from an accredited program preferred.
• Professional certification in Phlebotomy from a recognized program preferred.
• 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.
• Interpersonal and communication skills to interact effectively with professional, administrative staff, sponsors, regulatory representatives, patients, and referral sources.

Skills

• Training appropriate to anticipated duties (e.g., Medical Assistant, undergraduate, graduate degree, or equivalent).
• Ability to lift at least 30 lbs.
• Able to sit and type for long periods (at least 50%).

Schedule

Full-time, 40 hours per week, Monday-Friday, 7:00 AM - 4:00 PM.

Pay

$31.25 to $38.50 per hour, depending on experience.

Benefits

• Health, Dental, Vision (with HSA plans and employer contribution).
• 3 weeks PTO.
• 5 days Sick Time.
• 7 Company holidays + 2 Half-days.
• 401K with up to 6% company match.
• Short & Long Term Disability.
• Educational Assistance.
• Shared company vehicles for required travel.

Work Environment

• Clinic/office setting.
• Some interoffice travel may be required with use of company vehicle or mileage reimbursement.

Work Authorization

Must have valid documentation and authorization to work in the U.S. (visa sponsorship or transfer is not offered now or in the future).