Senior Clinical Monitor – Sponsor Oversight

Commonwealth Science and Technology; Boston (MA); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Clinical monitoring

Regulatory compliance

Quality standards

ICH-GCP knowledge

FDA regulations

Educación

Bachelor's degree in Life Sciences

Herramientas

EDC

CTMS

eTMF

Descripción del empleo

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.