Clinical Research Associate – Contract

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Oversee initiation activities for post-market observational studies, registries, and associated real-world evidence projects.

• Manage workflows for site feasibility, qualification, readiness assessment, and activation.

• Coordinate the collection, review, tracking, and follow-up of essential regulatory and start-up documentation.

• Assist in the negotiation and execution tracking of Clinical Trial Agreements, Statements of Work, budgets, purchase orders, and relevant site documentation.

• Facilitate site onboarding, which includes training for investigators and study staff, access to study systems, and preparation for initial subject enrollment.

• Conduct and record Site Initiation Visits (SIVs), covering protocol requirements, safety reporting expectations, EDC entry, product handling, and study workflow.

• Verify site access to EDC systems, study portals, imaging repositories, training platforms, and other study technologies.

• Monitor site start-up milestones, recognize activation risks or delays, and escalate issues with proposed solutions.

• Collaborate with Clinical Operations, Data Management, Regulatory Affairs, Quality, Pharmacovigilance, and external vendors to facilitate timely site activation.

• Conduct both remote and on-site monitoring visits, including initiation, routine monitoring, and closeout visits.

• Execute risk-based monitoring activities to ensure protocol compliance, subject safety, data quality, and regulatory compliance.

• Review study data to ensure completeness, consistency, and alignment with source documents as applicable to the study design.

• Issue, track, and facilitate resolution of site queries in partnership with Data Management and study teams.

• Monitor site performance metrics, enrollment progress, data entry timelines, protocol adherence, and completion of follow-ups.

• Identify site risks and assist in implementing corrective and preventive actions as necessary.

• Cultivate productive relationships with investigators, research coordinators, operating room staff, and other site personnel.

• Offer timely guidance, training, and support to sites throughout the study lifecycle.

• Maintain accurate, complete, and inspection-ready monitoring documentation and site correspondence.

• Support the quality, completeness, and essential document maintenance of the Trial Master File (TMF) during the study lifecycle.

• Document monitoring findings, action items, follow-up actions, and issue resolution promptly and traceably.

• Contribute to activities related to audit and inspection readiness.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Nursing, Public Health, Clinical Research, or a related discipline.

• At least 3 years of experience as a CRA, Clinical Research Coordinator, or in Clinical Operations.

• Proven experience in site start-up, site activation, and site management tasks.

• Experience in conducting monitoring visits, whether remotely or on-site.

• Familiarity with GCP, ISO 14155, relevant FDA regulations, and standards for clinical research documentation.

• Proficient in using EDC systems, remote monitoring tools, and clinical trial document repositories.

• Strong skills in communication, organization, follow-up, and project management.

• Willingness to travel approximately 25–40%, depending on study and site requirements.

🏝️ Benefits

• Competitive salary

• Remote work options

• Professional development opportunities

• Health insurance

• Paid time off