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Research Quality Compliance Coordinator

3 months ago

Peoria, United States Arizona Liver Health Full time

**About Us**:
Arizona Liver Health (ALH) is dedicated to driving high standards of care and advancing medical innovation by leading clinical trials, ensuring patient safety, regulatory compliance, and generating high-quality clinical trial data. Our network of multiphase, multitherapeutic research sites is staffed by skilled principal investigators and research professionals. ALH operates state-of-the-art facilities and programs to meet the evolving needs of clinical research and patient treatment.

**Role Summary**

Arizona Liver Health (ALH) is seeking an experienced **Research Quality Compliance Coordinator** in Peoria with a background in Clinical Research/Quality/Compliance/Regulatory. As a key member of our team, you will play a crucial role in ensuring the highest standards of scientific excellence.

**Title**:Research Quality Compliance Coordinator

**Compensation**: $60k - $70k, depending on experience and qualifications

**Status**: Full-time, 40 hours

**Location**:Peoria, AZ

**Essential job functions/duties**
- Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions._
- Ensure high integrity of data and patient safety at the research site through quality assurance review and management of the conduct of clinical research activities.
- Conduct routine data quality assurance checks,
- Review data for deviations, errors, omissions, or inconsistencies,
- Ensure studies are being conducted according to the applicable site SOPs,
- Work with the research staff and Principal Investigator to ensure identified issues are addressed in a timely and appropriate manner,
- Complete and review CAPAs as needed. Review CAPAs implementation as needed
- Work with clinic staff to address any audit findings from outside auditors (sponsor, CRO, IRB or FDA inspection findings)
- Ensure all required documentation is complete and appropriately filed.
- Liaison with study sponsors to resolve questions and/or concerns as needed
- Work with CRC to ensure understanding or required consistencies between source and EDC.
- Help in training research staff regarding QC (as designated)
- Meet with CRA at monitoring visits regarding findings. Engage other research staff as needed (regulatory coordinator, site manager, Director of Clinical Research).

**Knowledge/Skills/Abilities Required**
- A thorough understanding of regulatory requirements, principles of GCP and biomedical research ethics.
- Experience developing, managing, and reviewing Standard Operating Procedures (SOPs).
- Understanding of and experience in developing and supporting Corrective and Preventative Action Plans (CAPA).
- Ability to work independently, and in a fast-paced environment
- Attention to detail in all aspects of work
- Excellent collaboration skills
- Ability to work independently as well as in teams
- Excellent verbal and written communication skills
- Demonstrated ability to effectively organize and execute tasks
- Computer proficiency with Microsoft office and understanding of CTMS/EMR software
- High level of critical thinking

**Travel requirements**:

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

**Education, credentials, and/or trainings required**:

- Associates or Bachelor's degree in healthcare, clinical research management, or related required
- Training (appropriate to anticipated duties study-specific training, or other as applicable to assigned responsibilities).

**Benefits & Perks**:

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

**_Our company requires COVID-19 vaccinations for all current and future employees. Exemptions can be requested for those with a reasonable health or a religious/sincerely-held belief accommodation._**

**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