Clinical Research Coordinator II or III (CRC 2-3) AMP

Arizona Liver Health•Chandler, AZ

15h•$28 - $36

About The Position

Arizona Liver Health/Arizona Clinical Trials is looking for qualified candidates for the Clinical Research Coordinator II or III position in Chandler. 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.

Requirements

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
Know and understand all regulatory requirements associated with the conduct of the study assigned.
Associates or Bachelor's degree in healthcare, clinical research management, or related required.
GCP certification required at hire.
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)

Nice To Haves

Master’s degree or study-specific training preferred

Responsibilities

Manage the conduct of clinical research activities under the direction of the Principal Investigator or sub-investigator.
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 protocols and Informed Consent Forms for accuracy and clarity.
Recruit and screen potential participants, meeting recruitment goals for each study.
Implement and manage new clinical trials.
Provide educational information to subjects and serve as a resource for subjects and families.
Serve as a liaison to physicians, employees, and third-party vendors.
Record data and study documentation, keeping the clinical trial management system updated.
Plan, prepare and perform tasks required by protocol, including data recording, source documentation, and data correction.
Obtain patient medical history and medication lists.
Perform phlebotomy and basic laboratory tests, processing & shipping labs.
Provide patient education and training.
Perform ECG, administer questionnaires and assessments, and take vital signs.
Collect information for adverse event reporting and assist with efficacy assessments.
Perform data entry and query resolution.
Administer study drug, including injections.
Track study supply inventory and reorder when necessary.
Schedule patient visits and document all patient visits and communications.
Document and record all AEs and SAEs, monitor and report adverse events, and triage adverse events.
Manage site activities during audits and inspections.
Manage ancillary staff as assigned, train and supervise support staff, and mentor for externs.
Prepare for quality assurance audits and regulatory inspections and act as contact person during audits.
Participate in monitoring visits from sponsor provided appointees.
Other responsibilities as delegated by manager.