Senior Clinical Research Associate (Sponsor Oversight)
Company: Commonwealth Science and Technology
- Location: Boston, United States
- Seniority: Senior
- Employment type: Contract
- Posted: Yesterday
- Offer language: English
Job description
Position located in Boston, MA
Contract to Hire Opportunity!
Responsibilities:
- Provide clinical monitoring oversight and targeted site support to ensure clinical trials are conducted in accordance with study protocols, regulatory requirements, and established quality standards.
- Conduct site assessments, co-monitoring activities, and focused on-site visits based on study priorities and operational needs.
- Serve as a key contact for identifying and addressing site performance concerns, protocol deviations, data integrity issues, and other clinical monitoring challenges.
- Evaluate site preparedness and ongoing performance throughout the clinical trial lifecycle, including site initiation, patient enrollment, study conduct, and closeout.
- Review site performance metrics, including enrollment progress, protocol adherence, data entry timelines, and outstanding data queries.
- Identify sites requiring additional oversight and develop appropriate strategies to address performance gaps and operational risks.
- Partner with CRO monitoring teams to support CRA onboarding, training, and ongoing study execution.
- Assist with Trial Master File (TMF) maintenance, documentation quality, and overall inspection readiness.
- Coordinate the tracking and distribution of clinical trial materials, samples, and supplies as needed.
- Maintain accurate study records, monitoring trackers, and operational reports to communicate progress and identify potential issues.
- Participate in audit and regulatory inspection preparation, including follow-up activities related to monitoring findings.
- Identify opportunities to improve clinical operations workflows, monitoring practices, and study execution.
- Provide additional clinical operations support as needed to meet evolving study and program requirements.
Requirements:
- Bachelor's degree in Life Sciences or a related scientific discipline.
- Minimum of 5 years of Clinical Research Associate experience, including at least 3 years of independent site monitoring experience.
- Demonstrated experience supporting multicenter Phase II and/or Phase III clinical trials.
- Prior CRO experience is required; experience working within a sponsor organization or small biotechnology company is highly desirable.
- Strong understanding of clinical site monitoring, CRO oversight, and clinical trial operations.
- Working knowledge of ICH-GCP guidelines, FDA regulations, and applicable clinical research requirements.
- Experience working with clinical trial technologies, including EDC, CTMS, eTMF, and related study management platforms.
- Ability to independently assess study risks, recognize operational challenges, and proactively drive resolution.
