Assistant Research Manager (Chandler)
About Us
Aziz 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.
Job Summary
Aziz Liver Health is looking for exceptional candidates to fill the Assistant Research Manager role. Qualified candidates will possess great team leadership abilities and a passion for continuing to grow their skillset in clinical research. The Assistant Research Manager will manage the conduct of clinical research activities, coordinate and implement assigned protocols, collect and record clinical research data, assist in patient assessments, schedule, maintain study files, study supplies, and study medication accountability. They will also assist in the managing of the site research staff, train/retrain new research staff, and execute regular retrainings with current staff to maintain compliance and productivity. They will review weekly screening and clinic volume to meet and/or exceed goals, and report any daily issues/concerns, work quality issues to the Site Research Manager, and provide support to the site manager and clinical staff to ensure high quality, high volume, and efficient productivity.
Essential Job Functions/duties
- 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.
- Collections and records clinical research data, assists in patient assessments, schedules, maintains study files, study supplies and study medication accountability.
- Assists in the managing of the site research staff as directed by the Site Research Manager.
- Reviews weekly screening and clinic volume to meet and/or exceed goals.
- Regulatory and /or Quality Assurance/Quality Control duties at site as needed.
- Daily Research Operations.
- Assists in the managing of CRC 2, 3, research phlebotomist in the absence of the Site Research Manager.
- Reports any daily issues/concerns, work quality issues to the Site Research Manager.
- Provides support to the site manager and clinical staff to ensure high quality, high volume and efficient productivity.
- Help plan site specific team building activities.
- Reports to direct manager on status of daily clinical research operations.
- Maintain effective, and positive, working relationships with patients, sponsors, providers and employees.
- Troubleshoot and resolve clinic, protocol, and SOP issues and advise CRCs.
- Changes to SOPs and clinic process to be discussed with Chief Medical Officer and direct manager.
- Assist ad fill in for CRCs (level 1-3) with assigned tasks as necessary.
- Allocate work in cooperation with the Site Research Manager.
- Conduct timely evaluations and monthly one-on-one meetings (at minimum) for assigned direct reports (if any).
- Aid in establishing and enforcing departmental standards.
- Aid in conducting regularly scheduled meetings with the research personnel at the site as needed and take proper meeting notes with action items.
- Attend and present at scheduled meetings with research staff, direct manager, and Chief Medical Director of Research.
- Aid in projects and tasks as assigned and direct in the absence of the Site Research Manager.
- Provide assistance with study protocol adherence as necessary.
- Ensure site staff completes assigned tasks.
Knowledge/Skills/Abilities Required
- At least three to five (3-5) years of experience in a lead CRC role or a CRC III role or equivalent in either phase 1 or phase 2-3 research.
- A thorough understanding of regulatory requirements, principles of GCP and biomedical research ethics.
- Strong Interpersonal and 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.
- Can communicate clearly and effectively.
- Strong organization, time-management, and leadership skills.
- Able to maintain professional and positive attitude.
- To provide all employees and research subjects with an excellent service experience by consistently demonstrating professional decorum.
- Knowledge of FDA regulatory requirements is required.
- Has knowledge of commonly used concepts, practices and procedures within particular field.
- Rely on instructions and pre-established guidelines to perform the functions of the job.
- Work under immediate supervision of the Site Research Manager.
- Proven ability to perform all job functions as listed job descriptions for Research Phlebotomist, CRC I-III, and Research Pharmacy Tech.
- Interviewing and hiring team members with or on behalf of the site manager.
- Training of new team members as well as retraining of current team members.
- Timely execution of performance evaluations for assigned direct reports (if any).
- Provide mentorship and coaching to elevate skillsets of current team.
- Help plan both professional and personal goals with team members to ensure productivity and meeting assigned KPIs.
- Delegate responsibilities among team members as needed to ensure efficiency in the absence of the Site Research Manager.
- Aid in performing progressive disciplinary action and proper documentation in collaboration with Human Resources for team members as necessary.
Education And/or Trainings Required
- A High School Diploma or GED required.
- An Associates, undergraduate, graduate degree or equivalent.
- Five (5) years of work experience or graduate training preferably in clinical setting.
- Study-specific training.
- Experience and training in the conduct of clinical research (specific experience and/or training in clinical research, including IRB submissions, reporting and source documentation and trial management).
- Previous leadership experience preferred.
Physical Requirements
- Able to lift at least 25 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.
Benefits & Perks
- Health, Dental, Vision (with HSA plans and employer contribution)
- 3 weeks PTO
- 5 days Sick Time
- 7 Company Paid holidays + 2 Paid Half-days
- 401K with 6% company match
- Short & Long Term Disability
- Educational Assistance
- Shared company vehicles for required travel
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Other responsibilities may be communicated directly by the reporting manager/supervisor. Duties, responsibilities, and activities may change at any time with or without notice.