Job Summary
We are seeking a highly motivated and detail-oriented Senior Clinical Research Associate (SCRA) to join our dynamic clinical development team. In this pivotal role, you will oversee the execution of clinical trials, ensuring compliance with regulatory standards and maintaining the highest quality of research data. Your expertise will drive the successful progression of clinical studies, from site initiation through close-out, contributing to innovative healthcare solutions that impact patient lives worldwide. This position offers an exciting opportunity to lead complex projects, mentor junior staff, and uphold rigorous ethical and scientific standards in a fast-paced research environment.
The Clinical Research Associate is the primary conduit between our clinical study team and investigative sites. You will ensure the highest quality of data integrity and patient safety by conducting comprehensive monitoring visits and maintaining strong relationships with site personnel. This role is critical in ensuring that our trials are conducted in strict accordance with the study protocol, Standard Operating Procedures (SOPs), and ICH-GCP guidelines.
In addition to the roles and responsibilities below, the incumbent performs other duties and responsibilities as assigned. As a member of a collaborative, cross-functional team, employees may be asked to contribute to projects or initiatives outside their primary role as business needs evolve.
Key Responsibilities
· Site Management: Serve as the main point of contact for investigative sites, performing the full lifecycle of visits: Pre-study (PSV), Site Initiation (SIV), Routine Monitoring (RMV), and Close-out (COV).
· Data Integrity: Conduct Source Data Verification (SDV) and Source Data Review (SDR) to ensure CRF data matches medical records.
· Regulatory Compliance: Review Site Regulatory Binders/Trial Master Files (TMF) for completeness and accuracy.
· Patient Safety: Verify informed consent processes and ensure all Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported within required timelines.
· Drug Accountability: Track investigational product (IP) inventory, storage conditions, and dispensation logs.
· Reporting: Generate detailed monitoring reports and follow-up letters within 2 days of site visits, tracking action items to resolution.
· Mentorship: Trains and mentors junior level CRAs to assist in all aspects of site monitoring including, but not limited to, guiding the education on clinicaltrial protocols, and study processes, Good Clinical Practice (GCP) rules, and planning, conduct, documentation, and reporting for site monitoring visits.
· Leadership: Has direct supervisory responsibility for one or more junior level CRA(s). The Sr. CRA works closely with the junior CRA(s) to ensure performance expectations and project timelines are met. Reviews and approves monitoring visit reports. Conducts co-monitoring visits to assess quality and feedback from sites. Supports CRA’s professional development and ensures compliance with study and regulatory requirements.
The incumbent will be expected to also work closely with cross-functional project teams and vendors (e.g. central labs) to support study execution and ensure alignment with project goals.
Required Qualifications
- Education: Bachelor’s degree in a Life Science, Nursing, or related healthcare field. Equivalent experience will also be considered.
- Experience: Minimum of three (3) years of active independent field monitoring experience in a CRO or Pharmaceutical environment.
- Technical Knowledge: Deep understanding of ICH-GCP, FDA/EMA regulations, and local clinical trial requirements.
- Systems: Proficiency with Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), and eTMF platforms.
- Travel: Ability to travel overnight frequently (typically 8–10 monitoring days per month).
Skills & Attributes
- Therapeutic Expertise: Prior experience in metabolic disease.
- Certification: CCRA (ACRP) or CCRP (SOCRA) certification is a plus.
- Communication: Exceptional interpersonal skills with the ability to "firmly but fairly" manage site compliance issues.
- Autonomy: High level of self-motivation and the ability to manage a rigorous travel schedule independently.
Must be able to work effectively in an independent setting while leveraging resources to meet goals and objectives. Requires ability to manage multiple complex projects simultaneously. Requires development and management of strong working relationships with Company colleagues, as well as external organizations. Highly self-motivated to establish and meet deadlines. Recognizes and accepts the need for a flexible work schedule to meet long and irregular demands of this position. Maintains a professional and positive image and attitude regarding the Company. Demonstrate commitment to continued professional growth and development of self and staff.
Join us in advancing groundbreaking healthcare research by applying your expertise in a collaborative environment that values innovation, integrity, and excellence!
Benefits:
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Professional development assistance
- Vision insurance
Education:
Experience:
- Clinical research: 3 years (Required)
Location:
- Raleigh, NC 27609 (Required)
Work Location: In person
