Clinical Research Associate

Responsibilities:

• Serve as the primary monitor and main contact for assigned clinical sites, conducting interim monitoring visits and site file reviews.
• Perform source documentation verification, review electronic medical records, and ensure accurate data entry and reporting of protocol deviations.
• Verify adverse events and concomitant medications, supporting site staff including coordinators and physicians as needed.

Qualifications:

• BA/BS degree with a minimum of 2+ years of CRA experience or 5+ years for senior roles with lead monitor responsibilities.
• Therapeutic experience in oncology/hematology and cell/gene therapy preferred, with prior sponsor-side CRA experience in a start-up environment.
• Strong knowledge of FDA/ICH-GCP regulations, clinical monitoring procedures, and experience with eTMF, EDC, and CTMS systems.

Personal Qualities:

• Highly detail-oriented with strong organizational skills, ability to multitask, prioritize, and work under tight deadlines.
• Collaborative team player with excellent interpersonal and communication skills, and a strong problem-solving and process improvement mindset.
• Adaptable to a fast-paced, informal start-up environment, demonstrating a strong work ethic, curiosity, and a sense of humor.