Clinical Research Associate
$75 - $80 per hourInsync Consulting Services
Job Description
Job Description
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 .
InSync Consulting Services is a staffing agency specializing in Healthcare, Commercial, and EOR staffing services.
Company Description
InSync Consulting Services is a staffing agency specializing in Healthcare, Commercial, and EOR staffing services.
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