Location: New Haven, CT (Primarily Onsite with Remote Monitoring Activities)
Schedule: Part-Time | Flexible Scheduling
Duration: 6–10 Month Contract | Potential Temp-to-Perm
Pay: $75-$80

InSync Consulting is seeking a highly skilled professional to independently monitor Phase I and Phase II clinical trials, ensuring compliance with study protocols, ICH-GCP guidelines, and regulatory requirements. This is an excellent opportunity to support innovative clinical research while enjoying a flexible schedule with both onsite and remote monitoring responsibilities.

What You'll Do

• Conduct independent onsite and remote monitoring visits for Phase I and Phase II clinical trials.
• Perform source data verification (SDV) and review source documentation for accuracy and protocol compliance.
• Review informed consent forms, regulatory files, and study documentation.
• Prepare monitoring visit reports, follow-up letters, and site correspondence.
• Resolve Electronic Data Capture (EDC) queries and ensure timely site follow-up.
• Partner with investigators, study coordinators, sponsors, and research teams to support successful study execution.
• Identify protocol deviations, communicate findings, and drive resolution of action items.
• Ensure compliance with ICH-GCP, sponsor requirements, and applicable regulatory standards.

What We're Looking For

• Bachelor's degree in Life Sciences, Healthcare, Nursing, Public Health, or a related field.
• Current GCP certification
• Minimum of 3 years of independent clinical research monitoring experience.
• Experience monitoring Phase I and/or Phase II clinical trials.
• Strong knowledge of ICH-GCP, FDA regulations, and clinical trial compliance.
• Experience with Source Data Verification (SDV), Trial Master Files (TMF), and Electronic Data Capture (EDC) systems.
• Excellent written communication skills with experience preparing monitoring reports.
• Ability to independently manage monitoring activities with minimal supervision.

Preferred Qualifications

• Neuroscience or neurology clinical research experience.
• Imaging research experience (MRI, PET, CT, or related studies).
• ACRP, CCRP, SOCRA, or equivalent certification.

Schedule & Travel

• Approximately 8–10 monitoring visits per quarter.
• Onsite visits in New Haven, CT typically last 6–8 hours.
• Remote monitoring activities typically last 4–6 hours.
• Flexible scheduling with advance notice for onsite visits.

Pay: $75.00 - $80.00 per hour

Benefits:

• Flexible schedule

Education:

• Bachelor's (Required)

Experience:

• clinical research monitoring : 3 years (Required)

License/Certification:

• GCP (Good Clinical Practice) certification (Required)

Work Location: Hybrid remote in New Haven, CT 06510