Apply on Employer Site

Arizona Liver Health · 10 hours ago

Clinical Research Coordinator III (Phase I)

Chandler, AZ

Full-time

Onsite

Mid Level

$33/hr - $39/hr

4+ years exp

Arizona Liver Health (ALH) is dedicated to driving high standards of care and advancing medical innovation through leading clinical trials. The Clinical Research Coordinator III (Phase I) will manage clinical research activities, ensure compliance with regulatory standards, and develop strategies for participant engagement and retention.

Clinical TrialsHealth CareHospitalityMedical

No H1B

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

Qualification

Clinical research experienceRegulatory compliance knowledgeGCP principles understandingBLS certificationACLS certificationPhlebotomy certificationMedical Assistant trainingStudy-specific trainingInterpersonal skillsCommunication skills

Required

High School Diploma or GED required

BLS and ACLS training required

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

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