Senior Clinical Research Associate I

Responsibilities

• Perform routine and close-out monitoring visits to ensure studies are conducted in alignment with GCP, ICH, and applicable regulations.
• Serve as the primary point of contact for assigned research sites, fostering strong relationships and ongoing communication.
• Review site data, source documentation, and regulatory files to confirm accuracy, completeness, and protocol adherence.
• Provide guidance and training to site staff on protocol requirements, study procedures, and compliance expectations.
• Identify, document, and escalate quality or compliance concerns while supporting resolution efforts.

Qualifications

• 1–4 years of onsite clinical monitoring experience, aligned to CRA II or Senior CRA I level.
• Experience supporting clinical trials within cardiovascular, CNS, diabetes, or metabolic indications.
• Strong working knowledge of GCP, ICH guidelines, and FDA regulatory requirements.
• Proficiency with CTMS, EDC systems, and standard clinical trial documentation.
• Bachelor’s degree in life sciences, nursing, or a related discipline; Spanish fluency is highly preferred for candidates based in Florida or Puerto Rico.

Pay

Salary Range: $115,000–$125,000/year (USD)

Benefits

• Medical
• Dental
• Vision
• sick leave if required by law
• 401(k)