Research Manager (Flagstaff)

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.

About the role

Arizona Liver Health is looking for exceptional candidates to fill the Research Manager role. Qualified candidates will possess great team leadership abilities and a passion for continuing to grow their skillset in clinical research.

Location: Flagstaff, AZ (Onsite)
Status: Full-time, Exempt
Schedule: Monday-Friday, 7am-4pm
Compensation: $95k-$120k per year, depending on experience

Responsibilities

• 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.
• Collect and record clinical research data, assist in patient assessments, scheduling, maintaining study files, study supplies, and study medication accountability.
• Perform Clinical Research Coordinator (CRC) responsibilities as listed in the Job Description, including:
  • The day-to-day operations of the research program
  • Approve flexing of time worked
  • Collaborate with the recruitment team to recruit patients into trials and meet site visit and revenue goals
  • Execute accurate data entry into the EDC and CTMS for patient visits and other pertinent research information as required
  • Train/retrain new research staff with annual retraining and as needed
  • Review weekly screening and clinic volume to meet and/or exceed goals
  • Perform regulatory and/or Quality Assurance/Quality Control duties at the site as needed
  • Daily research operations
• Manage CRC 2, 3, research phlebotomist, pharmacy technicians, and other research personnel outside of advanced practice providers.
• Address daily issues/concerns and work quality; triage issues for escalation to the Director of Clinical Research as needed. Serious issues to be referred to the Director of Human Resources and Chief Medical Director of Research immediately.
• Provide leadership and support to the clinical staff to ensure high quality, high volume, and efficient productivity.
• Conduct site-specific team-building activities, including proactive team building and incentive/rewards programs.
• Maintain effective and positive working relationships with patients, sponsors, providers, and employees.
• Troubleshoot and resolve clinic, protocol, and SOP issues; advise CRCs on changes to SOPs and clinic processes to be discussed with the Chief Medical Officer and Director of Clinical Research.
• Execute and fill in for CRCs (level 1-3), phlebotomists, pharmacy techs, and patient recruitment with assigned tasks as necessary.
• Assist in establishing and enforcing departmental standards.
• Conduct weekly meetings with research personnel at the site.
• Attend and present at scheduled meetings with research staff and leadership.
• Direct/assist with projects and tasks as assigned.
• Provide assistance with study protocol adherence as necessary.
• Ensure site staff completes assigned tasks.

Requirements

• A thorough understanding of regulatory requirements, principles of GCP, and biomedical research ethics.
• Strong interpersonal, communication, and customer service skills, both verbal and written. Able to interact effectively with professional, administrative staff, sponsor and regulatory representatives, patients, potential subjects, and referral sources.
• Strong organization, time-management, and leadership skills.
• Ability to maintain a professional and positive attitude.
• Ability to provide all employees and research subjects with an excellent service experience by consistently demonstrating professional decorum.
• Knowledge of FDA regulatory requirements.
• Knowledge of commonly used concepts, practices, and procedures within the field.
• Able to perform all job duties listed for the Phlebotomist job description.

Qualifications

• High School Diploma or GED required.
• Associate’s, undergraduate, graduate degree, or equivalent.
• Seven (7) years of work experience or graduate training, preferably in a clinical setting.
• Study-specific training.
• Experience and training in the conduct of clinical research, including IRB submissions, reporting, source documentation, and trial management.
• Managerial experience and/or training.

Physical Requirements

• Able to lift at least 25 lbs.
• Able to walk and stand for at least 50% of the day.
• Able to sit for at least 50% of the day.
• Communicate: hearing, talking, vision.
• Able to type and do computer work for long periods.

Travel Requirements

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

Work Authorization

Must have valid documentation and authorization to work in the U.S. for any employer. Sponsorship, work visa, and/or visa transfer is not provided.