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

About the role

AzLH is a dedicated organization focused on advancing medical innovation through 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. AzLH operates state-of-the-art facilities and programs to meet the evolving needs of clinical research and overall patient treatment.

Responsibilities

• Manage the conduct of clinical research activities under the direction of the Principal Investigator or sub-investigator.
• Implement assigned protocols in compliance with FDA CFR, GCP, and company SOPs.
• Collect and record clinical research data, assist in patient assessments, schedule, maintain study files, study supplies, and study medication accountability.
• Develop management systems and prepare for study initiation.
• Review inclusion/exclusion criteria, overall structure, and requirements of each protocol.
• Review protocol summary sheets and Informed Consent Forms for accuracy and clarity.
• Recruit and screen potential participants, including chart reviews, scheduling, contacting leads, 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, procedures, regulatory, and accreditation requirements.
• Provide educational information to subjects, serve as a resource and support person, and demonstrate professional decorum.
• Serve as a liaison to physicians, employees, and third-party vendors.
• Record data and study documentation, keep the clinical trial management system updated, and ensure status of each patient is accurate.
• Assign patient stipend pay cards at screening, document reasons for screen-fail in real time, plan, prepare, and perform tasks required by protocol, and correct and edit data as directed.
• Obtain patient medical history and medication lists, perform phlebotomy and basic laboratory tests, process and ship labs, administer questionnaires and assessments, collect vital signs, and document all patient visits and communications.
• Assist with adverse event reporting, perform efficacy assessments, and data entry and query resolution.
• Administer study drugs, track supply inventory, and reorder when necessary.
• Document adverse events and serious adverse events, triage them, and communicate with the research physician.
• Ensure W-9 and medical release forms are signed by subjects annually.
• Manage site activities during audits and inspections, manage ancillary staff as assigned, train and supervise support staff, mentor for externs, and prepare for quality assurance audits and regulatory inspections.
• Participate in monitoring visits from sponsor provided appointees, ensure monitors meet with PI, and address concerns in a timely manner.
• Participate in other responsibilities as delegated by manager.

Requirements

• Minimum 2 years of experience working as a Clinical Research Coordinator for late phase clinical trials.
• Training and experience in the conduct of 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 various stakeholders.
• Able to perform all job duties listed for the Job Description for Phlebotomist.
• Knowledge of all regulatory requirements associated with the study assigned.
• Associates or Bachelor's degree in healthcare, clinical research management, or related field.
• Master’s degree or study-specific training preferred.
• GCP certification required at hire.
• Experience and training in clinical research recruitment, including IRB submissions and trial enrollment management.
• Experience with data management and tracking software.

Qualifications

• Associates or Bachelor's degree in healthcare, clinical research management, or related field.
• Master’s degree or study-specific training preferred.
• GCP certification required at hire.
• Experience and training in clinical research, including IRB submissions, reporting, and source documentation, trial management.
• Able to perform all job duties listed for the Job Description for Phlebotomist.
• Knowledge of all regulatory requirements associated with the study assigned.

Skills

• Interpersonal and communication skills.
• Thorough understanding of regulatory requirements, principles of GCP, and biomedical research ethics.
• Ability to perform all job duties listed for the Job Description for Phlebotomist.
• Knowledge of all regulatory requirements associated with the study assigned.

Benefits & Perks

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

Pay

$27.50 to $36 per hour, depending on experience.

Schedule

Monday-Friday, 7am-4pm (set schedule).