Gandiv Insights LLC · 7 hours ago
Clinical Research Associate (CRA)
Boston, MA
Contract
Onsite
Mid, Senior Level
3+ years expGandiv Insights LLC is seeking a Clinical Research Associate (CRA) to independently monitor clinical trial sites. The CRA will ensure compliance with study protocols and regulatory requirements while supporting study start-up, execution, and close-out activities.
Information Technology & Services
Responsibilities
Conduct site monitoring visits (PSV, SIV, IMV, COV) per Clinical Monitoring Plan
Review and maintain essential documents including protocols, ICFs, CRFs, DOAs, ISF, and regulatory files
Perform source data verification (SDV) and ensure data integrity per ALCOA+ principles
Prepare monitoring reports and follow-up letters in a timely manner
Ensure TMF/eTMF accuracy and site audit readiness
Manage investigational product accountability and reconciliation
Support patient recruitment, site training, and investigator meetings
Collaborate with cross-functional teams and ensure compliance with SOPs and GCP
Qualification
Required
Bachelor's degree in Life Sciences or related field
3–5+ years of CRA monitoring experience
Strong knowledge of ICH-GCP, FDA regulations, and clinical trial processes
Hands-on experience with EDC, CTMS, eTMF systems
Excellent communication, documentation, and organizational skills
Preferred
Master's degree
Experience in Oncology, CNS, or Medical Device trials
Company
Gandiv Insights LLC
Gandiv Insights is a leading professional services and staffing firm specializing in top-tier personnel and technical solutions across engineering, IT, non-IT, and healthcare sectors.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase