Clinical Research Coordinator III (Phase I)

Arizona Liver Health•Chandler, AZ

1d•$33 - $39•Onsite

About The Position

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

Training (appropriate to anticipated duties – Medical Assistant, associates, undergraduate, graduate degree or equivalent, study-specific training, other as applicable to assigned responsibilities).
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.
High School Diploma or GED required.
BLS and ACLS training required.
4+ years of experience in clinical research field
Must have valid documentation and authorization to work in the U.S. -- visa sponsorship or visa transfer is not offered now or in the future
Able to lift at least 30 lbs.
Able to sit for long periods (at least 50%).
Able to type and do computer work for long periods.

Nice To Haves

Bachelor’s degree preferred.
Medical Assistant certification or diploma from an accredited program preferred.
Professional certification in Phlebotomy from a recognized program preferred.

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.
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 supplies to Phase 1 staff member.
Keep drawers, closets stocked with needed supplies.