Senior Clinical Research Associate (Sponsor Oversight)

Commonwealth Science and Technology; Boston (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Commonwealth Science and Technology in Boston seeks a seasoned Clinical Research Associate to provide clinical monitoring oversight and targeted site support, ensuring trials adhere to study protocols, regulatory requirements, and quality standards.

You will conduct site assessments, co-monitoring activities, and focused on-site visits, serving as the main contact for site performance concerns, protocol deviations, data integrity issues, and operational risks.

Qualifications

• Bachelor's degree in Life Sciences or related field required.
• Minimum 5 years of Clinical Research Associate experience, including at least 3 years independent site monitoring.
• Experience supporting multicenter Phase II/III trials.
• Prior CRO experience required; sponsor or biotech experience desirable.
• Strong understanding of clinical site monitoring, CRO oversight, and trial operations.
• Working knowledge of ICH-GCP, FDA regulations, and clinical research requirements.
• Experience with EDC, CTMS, eTMF, and study management platforms.

Responsibilities

• Provide clinical monitoring oversight and targeted site support to ensure trials follow protocols and quality standards.
• Conduct site assessments, co-monitoring activities, and focused on-site visits.
• Identify and address site performance concerns, protocol deviations, and data integrity issues.
• Evaluate site readiness across initiation, enrollment, conduct, and closeout; review performance metrics.
• Coordinate TMF maintenance, trial materials, and regulatory inspections.

Skills

Clinical monitoring

Regulatory compliance

Quality standards

ICH-GCP knowledge

FDA regulations

Education

Bachelor's degree in Life Sciences

Tools

EDC

CTMS

eTMF

Job description

• 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.