Phase 1 Clinical Research Coordinator (Full-time, Tue-Thu, 7PM-7AM)

Schedule: Overnight Shift (Full-time, Tuesday through Thursday, 7:00 PM to 7:00 AM)

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

Knowledge/Skills/Abilities 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.

Education, credentials, and/or trainings required 

• Associate Degree in Nursing (ADN) from an accredited nursing program required; Bachelor of Science in Nursing (BSN) preferred.
• Current, unrestricted Registered Nurse license issued by the Arizona State Board of Nursing, or a current multistate RN license with privilege to practice in Arizona, required.
• Current Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) certifications required.
• Minimum of one year of professional nursing experience in a clinic, hospital, acute care, outpatient, or clinical research setting required; experience in Phase 1 clinical research preferred.
• Completion of Good Clinical Practice (GCP), human-subject protection, and study-specific training within required company timelines.
• Competency in venipuncture, intravenous access, medication administration, and other protocol-required nursing procedures required; additional research or specialty certifications preferred.

Supervisory responsibilities 

• None. 

Work environment 

Clinic setting 

Physical demands 

• 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. 

Travel Requirements 

• Some interoffice travel may be required with use of company vehicle or mileage reimbursement. 

Work authorization requirements

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

Benefits & Perks:

• Health, Dental, Vision (with HSA plans and employer contribution)
• Paid Time Off
• 5 days Sick Time
• 7 Company holidays + 2 Half-days
• 401K with up to 6% company match
• Short & Long Term Disability
• Educational Assistance
• Shared company vehicles for required travel

EEO statement

It is the policy of the Institute for Liver Health DBA Arizona Liver Health and Arizona Clinical Trials to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law. This policy relates to all phases of employment, including, but not limited to, recruiting, employment, placement, promotion, transfer, demotion, reduction of workforce and termination, rates of pay or other forms of compensation, selection for training, the use of all facilities, and participation in all company-sponsored employee activities. Provisions in applicable laws providing for bona fide occupational qualifications, business necessity or age limitations will be adhered to by the company where appropriate.

Notice to Staffing Agencies: It is our policy that any and all contact with third party staffing or recruitment vendors come through our Talent Acquisition Team directly. We have an established and preferred network of contracted partners that we engage if and when we deem it necessary. We request that staffing agencies refrain from repeatedly contacting our hiring managers or employees directly. Unsolicited resumes, onsite solicitations, and inquiries will not be considered or responded to. Overly persistent and pushy inquires may also be blocked across our network as spam. Thank you for your understanding and cooperation.