Clinical Research Coordinator II (CRC2) Flagstaff

arizonaliverhealth

Flagstaff4d ago

Seniority: Mid

About the role

<div class="content-intro">  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.  </div>Job Summary: Arizona Liver Health/Arizona Clinical Trials is looking for qualified candidates for the Clinical Research Coordinator II position in Flagstaff. <hr> Title: Clinical Research Coordinator II (CRC2) Compensation: $27.50 - $36.00 per hour, depending on experience and qualifications Status: Full-time, Non-exempt, Hourly Location: Flagstaff, AZ (onsite) Monday-Friday, 7am-4pm <hr> Essential job functions/duties: Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Participant Recruitment & Enrollment:  <ul> <li>Identify, screen, and recruit eligible participants according to study protocol and inclusion/exclusion criteria. </li> <li>Conduct informed consent process and ensure documentation is complete and properly stored. </li> <li>Maintain participant retention efforts; schedule and follow up with participants for visits and assessments. </li> </ul> Research Procedures & Clinical Duties:  <ul> <li>Phlebotomy: collect, label, process, and ship blood and other biospecimens as required. </li> <li>Pharmacy Tech: assist with investigational drug handling, storage, dispensing, accountability logs, and inventory management of study medications or investigational products as permitted. </li> <li>Take vital signs, height/weight measurements, ECGs (if applicable), and other protocol‐specified assessments </li> <li>Follow study procedures to ensure participant safety, monitor adverse events (AEs) and serious adverse events (SAEs), report as required. </li> </ul> Data Management & Entry:  <ul> <li>Enter data accurately into source documents and electronic databases / Electronic Data Capture (EDC) systems. </li> <li>Maintain, update, and monitor case report forms (CRFs), sponsor forms, regulatory files, source documentation. </li> <li>Query resolution: respond to data queries from monitors or sponsors in a timely manner. </li> <li>Ensure data integrity, consistency, and completeness. </li> </ul> Regulatory Compliance & Documentation:  <ul> <li>Prepare, maintain, and submit regulatory documents in collaboration with the internal Regulatory team: Institutional Review Board (IRB) submissions, amendments, renewals. </li> <li>Ensure study compliance with Good Clinical Practice (GCP), FDA, ICH, or other applicable regulatory guidelines. </li> <li>Manage study files, regulatory binders, SOPs (standard operating procedures), study protocols. </li> <li>Participate in monitoring visits, audits, and ensure corrective action of findings. </li> </ul> Study Operations & Coordination:  <ul> <li>Conduct all patient visits for assigned studies and follow all standard operating procedures (SOPs) accurately as outlined in study protocol. </li> <li>Meet key performance indicators (KPIs) regarding visit goals </li> <li>Schedule study visits and ensure all protocol procedures are done on schedule. </li> <li>Report all Significant Adverse Events (SAEs) in a timely manner </li> <li>Collaborate with labs, pharmacies, imaging, vendors, sponsors, and internal clinical staff to ensure smooth execution of trial procedures. </li> <li>Maintain inventory of supplies and study materials; ensure equipment is calibrated and functioning. </li> <li>Assist in managing investigator meetings, site initiation, close‐out visits. </li> </ul> Additional duties to be assigned to role as applicable:  <ul> <li>Conduct Clinical Research study visits when assigned </li> <li>Communicate with sponsors effectively and professionally and in a timely manner to resolve issues or provide updates as needed </li> <li>Provide guidance as needed for CRC level I staff </li> <li>Audit research trials </li> <li>Perform vital signs, arthrometric measurements, transient elastography, and EKG’s </li> <li>Quality control research visits and informed consent before screening visit is over </li> <li>Confirm correct IP prior to dispensation </li> <li>File the signed copy in the subject binder(s) </li> </ul> Knowledge/Skills/Abilities Required  <ul> <li>Good knowledge of commonly used concepts, practices, and procedures in Research field </li> <li>Strong attention to detail </li> <li>Excellent communication skills </li> <li>Strong data management skills </li> <li>Excellent bedside management/patient communication skills </li> <li>Ability to train junior staff members (CRC I’s) as needed </li> </ul> <hr> Travel requirements: <ul> <li>Some interoffice travel may be required with use of company vehicle or mileage reimbursement</li> </ul> <hr> Education, credentials, and/or trainings required: <ul> <li>High School Diploma or GED required from an accredited institution </li> <li>Good Clinical Practice (GCP) certification (can be completed upon hire) </li> <li>IATA certification (can be completed upon hire) </li> <li>Bachelor’s degree in health sciences, healthcare administration, healthcare compliance, or related field preferred </li> <li>1- 3+ years of experience in the field or in a related area </li> </ul> Benefits: <ul> <li>Health, Dental, Vision (with HSA plans and employer contribution)</li> <li>3 weeks PTO (accural)</li> <li>7 Company holidays + 2 half-days</li> <li>5 days Sick Time</li> <li>401K with 6% company match</li> <li>Short & Long Term Disability</li> <li>CEUs / Educational Assistance</li> <li>Shared company vehicles for required travel</li> </ul> <hr> 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.  Notice to Staffing Agencies: It is our policy that any and all contact with third party staffing or recruitment vendors come through our Talent Acquisition Team directly. We have an established and preferred network of contracted partners that we engage if and when we deem it necessary. We request that staffing agencies refrain from repeatedly contacting our hiring managers or employees directly. Unsolicited resumes, onsite solicitations, and inquiries will not be considered or responded to. Overly persistent and pushy inquires may also be blocked across our network as spam. Thank you for your understanding and cooperation.

Perks & benefits

401k
Paid Time Off
Pension Matching

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