Clinical Research Assistant

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 D

• oConduct 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 F

• orBachelor's degree in Life Sciences, Healthcare, Nursing, Public Health, or a related fiel
• d.Current GCP certificati
• onMinimum of 3 years of independent clinical research monitoring experienc
• e.Experience monitoring Phase I and/or Phase II clinical trial
• s.Strong knowledge of ICH-GCP, FDA regulations, and clinical trial complianc
• e.Experience with Source Data Verification (SDV), Trial Master Files (TMF), and Electronic Data Capture (EDC) system
• s.Excellent written communication skills with experience preparing monitoring report
• s.Ability to independently manage monitoring activities with minimal supervisio

n.
Preferred Qualificati

• onsNeuroscience or neurology clinical research experien
• ce.Imaging research experience (MRI, PET, CT, or related studie
• s).ACRP, CCRP, SOCRA, or equivalent certificati

on.
Schedule & Tr

• avelApproximately 8–10 monitoring visits per quar
• ter.Onsite visits in New Haven, CT typically last 6–8 ho
• urs.Remote monitoring activities typically last 4–6 ho
• urs.Flexible scheduling with advance notice for onsite vis