Senior CRA, Clinical Trial Monitor

This is a fully remote position, open to applicants in United States.

📋 Description

• Execute site initiation, interim monitoring, and close-out visits, both in-person and remotely.

• Conduct source document verification, review informed consent, and assess compliance with protocols and GCP.

• Analyze documentation and reporting related to adverse events and serious adverse events.

• Oversee accountability, storage, and reconciliation of investigational products.

• Prepare monitoring reports, pinpoint deficiencies, and establish and monitor corrective and preventive actions (CAPA).

• Assist with NIH- or FDA-regulated clinical research initiatives.

• Collaborate with Government clinical investigators, regulatory personnel, and program officials in a multidisciplinary team setting.

• Travel as necessary.

⛳️ Requirements

• Bachelor's degree in a life science, nursing, or health-related discipline.

• A minimum of 5 years of experience in clinical monitoring, including at least 3 years on NIH- or FDA-regulated trials.

• Practical experience in conducting site initiation, interim monitoring, and close-out visits, both on-site and remotely.

• Proficient in source document verification, informed consent review, and protocol and GCP compliance assessment.

• Experience in reviewing documentation and reporting for adverse and serious adverse events.

• Knowledgeable in investigational product accountability, storage, and reconciliation procedures.

• Capability to produce clear monitoring reports, identify deficiencies, and formulate and track corrective and preventive actions (CAPA).

• Readiness and capacity to travel as needed.

• At least five years of direct experience supporting NIH or FDA-regulated clinical research programs.

• Familiarity with Good Clinical Practice (ICH E6), 21 CFR Parts 11, 50, 54, 56, 312, and 812 (as applicable), 45 CFR Part 46, and HIPAA.

• Current training in human subjects protections and GCP (e.g., CITI or equivalent).

• Experience working in a multidisciplinary team environment alongside Government clinical investigators, regulatory staff, and program officials.

• Clinical research certification (CCRA, CCRP) is preferred.

🏝️ Benefits

• Competitive compensation.

• Various benefit options.