Clinical Research Associate (Woburn)

We are seeking a detail-oriented and motivated Clinical Research Associate (CRA) to join our clinical operations team in a contract role. The CRA will be responsible for monitoring clinical trials, ensuring compliance with protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. This role plays a key part in ensuring the safety of study participants and the integrity of the clinical data collected.Key ResponsibilitiesStudy Monitoring: Conduct site qualification, initiation, monitoring, and close-out visits in accordance with study protocols, SOPs, and regulatory pliance Oversight: Ensure adherence to ICH-GCP, FDA regulations, and other applicable local/global regulations.Data Quality: Verify accuracy, completeness, and consistency of case report forms (CRFs) and source data. Identify and resolve data discrepancies with investigational sites.Site Management: Develop and maintain strong relationships with investigators, site staff, and study coordinators to ensure effective study execution.Documentation: Prepare detailed monitoring reports, track site performance, and maintain essential trial documents.Issue Resolution: Identify, document, and follow up on protocol deviations, regulatory issues, and other study-related concerns.Collaboration: Work closely with project managers, clinical trial managers, and cross-functional teams to support study timelines and deliverables.Training & Support: Provide protocol and study-specific training to investigational site staff as needed.May help in representing Clinical affairs in new product development teams and or be a clinical functional liaisonQualifications:Bachelors degree required. Degree in Life Sciences or health sciences or nursing or other related field preferred.Must have at least 2 years of work experience in Clinical Research as a study coordinator or research assistant in a hospital setting or within a CRO. Monitoring experience is a plus.Knowledge of clinical trial methodology and GCP/ICH guidelines preferred.Experience assisting in clinical operations tasks such as evaluating clinical trial sites and other study start-up, study follow up activities (drafting study manuals, acting as a liaison with clinical sites at various phases of study conduct).This individual may help in study budget activities including study related payments, accruals, etc.The ideal candidate will have keen attention to detail, be organized, and be a great communicator.Some travel may be needed (Not to exceed 20%).

Created: 2025-09-23