Primus Pharmaceuticals is seeking a versatile Clinical Research Associate (CRA) to support the conduct of prescription medical foods clinical trials at a growing pharmaceutical company. This role offers a mix of remote monitoring, site activities, and in-office collaboration at our Scottsdale headquarters. This role is ideal for a professional who enjoys both hands-on site engagement and strategic oversight responsibilities in a fast-paced environment.
Primus is an innovative company with novel products based on unmet needs that empowers providers and patients with prescription brands that maintain the highest level of safety without compromising efficacy. We are scaling proven brands into their next chapter, and the ideal candidate will find this motivating and have the leadership and skills to drive results.
Position Overview
The CRA will collaborate closely with Primus, the vendors, and investigative sites to ensure high-quality, compliant study execution. This role requires effective communication, and the fostering of strong site relationships and operational excellence.
Roles & Responsibilities
Vendor & Site Oversight
- Provide operational oversight of monitoring activities, including the development of monitoring visit reports, follow-up letters, and issues escalation.
- Track site and vendor performance against key deliverables, KPIs, and study timelines.
- Review Trial Master File (TMF) content for accuracy and completeness.
- Contribute to study-specific documents, including monitoring, communication, and risk management plans.
In-Field & Site Monitoring
- Conduct qualification, initiation, interim monitoring, and close-out visits at investigational sites as needed.
- Verify informed consent documentation, source data, case report forms (CRFs), investigational product accountability, and protocol compliance.
- Identify and resolve protocol deviations, compliance issues, and data discrepancies directly with site personnel.
- Serve as the primary point of contact for assigned sites, building strong relationships with investigators and staff.
- Provide ongoing training and support to sites on protocol requirements, study tools, and GCP compliance.
Cross-Functional Support
- Collaborate with internal teams (Clinical Development, Regulatory, Data Management, Safety, Quality) to ensure aligned trial execution.
- Support the design, development, and refinement of essential clinical trial documents, including Case Report Forms (CRFs), monitoring plans, and study-specific instructional manuals.
- Support audit/inspection of readiness and contribute to corrective/preventive action (CAPA) planning.
- Assist in site and vendor governance meetings by providing operational feedback and insights.
Qualifications
Education & Experience
- Bachelor’s degree in life sciences, nursing, pharmacy, or related field. (Requirement may be waived for candidates with 5+ years of directly relevant professional experience) .
- 3–6 years of clinical research experience, including at least 2 years as a CRA.
- Experience in both site/vendor oversight and direct site monitoring (pharma, biotech or CRO background preferred).
Technical Skills
- EDC Proficiency: Strong technical experience using Electronic Data Capture (EDC) platforms for data entry, query management, and source data verification (SDV).
- Platform Knowledge: Familiarity with industry-standard platforms such as Medidata Rave, Veeva Vault EDC, JotForm or Medrio.
- Compliance: Deep knowledge of ICH-GCP, FDA regulations, 21 CFR Part 11, and standard clinical trial processes.
General Skills
- Demonstrated ability to manage multiple sites/trials across various therapeutic areas.
- Excellent communication, organizational, and problem-solving skills.
- Willingness to travel (approximately 10–20%).
- Comfortable working in a smaller pharmaceutical setting with the flexibility to take on broad responsibilities.
About Primus Pharmaceuticals, Inc.
Primus innovates in prescription nutritional therapies targeting metabolic causes of chronic diseases across rheumatology, dermatology, and women’s health. We develop and commercialize first-in-class products and novel deliveries in Rx drugs, medical foods, and medical devices to fill key unmet needs with universal patient access not provided by traditional pharma. Visit our website at www.primusrx.com.
