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ABOUT VITALIEF

Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. We bring deep clinical research expertise together with practical, results-driven consulting to help organizations operate more efficiently and achieve sustainable growth.

THE ROLE

We are seeking a highly skilled and motivated Clinical Research Associate (CRA) to support our pharmaceutical client, based in the Phoenix, AZ area, in executing multiple clinical trials focused on chronic diseases — particularly those involving inflammation, dermatologic conditions, and metabolic disorders.

This hybrid role combines CRO oversight responsibilities with hands-on monitoring activities, offering the opportunity to contribute both strategically and operationally. The ideal candidate will thrive in a dynamic, fast-paced biotech environment and bring a collaborative, proactive approach to ensuring high-quality, compliant study delivery.

Work Hours: Part-time, 20 hours/week (potential to increase)

Duration: 12-month contract (possible extension)

Compensation: Market competitive, commensurate with experience

KEY RESPONSIBILITIES:

Clinical Operations & Monitoring

+ Support several concurrent trials (fewer than 10 sites nationally) through proactive coordination and oversight.

+ Conduct remote and on-site monitoring visits, including qualification, initiation, interim, and closeout activities.

+ Perform Source Document Verification (SDV) and ensure data accuracy, completeness, and protocol compliance.

+ Review clinical documentation (e.g., CRFs, monitoring plans, data management plans) for quality and consistency.

+ Serve as a key liaison for assigned investigational sites, fostering productive, long-term relationships with investigators and study staff.

+ Provide ongoing training and guidance to site teams on study procedures, GCP compliance, and protocol adherence.

CRO & Vendor Oversight

+ Provide operational oversight of CRO monitoring activities, including review of visit reports, follow-up letters, and issue escalation.

+ Track CRO performance metrics, deliverables, and milestones to ensure alignment with study timelines and quality expectations.

+ Review and maintain Trial Master File (TMF) content for accuracy, timeliness, and completeness.

+ Contribute to study documentation such as monitoring plans, communication plans, and risk management plans.

Cross-Functional Collaboration

+ Partner closely with Clinical Development, Regulatory, Data Management, Safety, and Quality teams to ensure seamless trial execution.

+ Support audit and inspection readiness efforts and assist with CAPA (Corrective and Preventive Action) plans when required.

+ Participate in governance and vendor meetings, providing operational insights and recommendations to enhance study performance.

QUALIFICATIONS:

+ Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related discipline.

+ 3–6 years of clinical research experience, including at least 2 years as a CRA.

+ Proven experience in both CRO/vendor oversight and direct site monitoring (sponsor or CRO setting).

+ Comprehensive understanding of ICH-GCP, FDA regulations, and clinical research processes.

+ Demonstrated ability to manage multiple studies across therapeutic areas (non-oncology preferred).

+ Strong communication, organizational, and analytical skills with keen attention to detail.

+ Proactive, adaptable, and comfortable working in a smaller biotech environment with broad responsibilities.

+ Willingness to travel nationally (up to 15%).

PHYSICAL DEMANDS: Prolonged periods of sitting at a desk and working at a computer.  Standing, walking, visual perception, talking and hearing.  Lifting up to 20lbs.  Ability to travel nationally (up to 15%).

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