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Clinical Research Coordinator II/III (Phase I)

External
arizonaliverhealth logoArizonaliverhealth · Chandler, AZ
$65K–$77K/yrFull-timeOn-site1mo ago30+ days old, may be filled
Clinical TrialsComplianceDocumentationGCP
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About the role

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. Title: Clinical Research Coordinator II / III (Phase I) Compensation: $65,000-$77,000 per year, depending on experience Location: Chandler, AZ Schedule: Full-time, 40 hours, Monday-Friday, 7am - 4pm Essential job functions/duties Reasonable accommodation may be made to enable individuals with disabilities to perform these essential functions. 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. Responsible for coordinating and implementing assigned protocols in compliance with FDA CFR, GCP and company SOPs. May assume responsibility in the implementation and management of new clinical trials in a knowledgeable and collaborative manner. Collects and records clinical research data, assists 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 the participants and investigators and ensuring 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. Documentation may be electronic or on paper depending on the trial. All "wet ink" documents will be filed in a binder or folder to pass off to the oncoming staff or clinical research coordinator. Record data and study documentation. Record data as directed using the appropriate media or platform. Follow procedures for access and security for electronic data entry. After proper training and delegation this position will be required to perform all study related procedures required on their shift and in preparation for the next shift. The procedures may include performing ecgs, vital signs, administering subject home medication, administering IP (Investigational Product/study drug) under direction of pharmacy staff, administer questionnaires as required per protocol, start iv's after, draw and process blood per lab manual, urine collection, keep intake and output sheets, collect and process bodily secretions per study guidelines. Other duties as assigned to keep in compliance with protocol requirements and data collection. Answer phone calls and direct appropriately. Order subject meals and ensure they eat per protocol requirements. Ensure subject and staff meals are within company guidelines. Manage study-related activities, subject compliance and documentation. Screen and enroll study subjects. Document all adverse events as required per protocol. Investigator and/or clinical coordinator should be notified in a timely manner of any potential adverse reactions. Management of site activities during audits and inspections. Prepare for quality assurance audits and regulatory inspections as needed. Act as contact person before, during and after audits and inspections. If new subjects check in to the unit during your shift, ensure all bags are checked for prohibited items. If these items are found, they should be confiscated and locked in a secure area for the safety of all subjects and staff. This will include cigarettes and lighters, pocket knives, subject home meds, etc. Perform all duties according to established policies, procedures, regulatory requirements, as well as applicable professional standards. Training in BLS/ACLS per company policy. Call 911 if emergency situation arises and notify the investigator immediately. Notify investigator or other delegated staff of any changes in subject status or reports of complaints by subject. Administer over-the-counter medication under direction of investigator. Assist subject with hygiene needs as required. 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, etc. Order or provide list of needed

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