Oncology CRA — Hybrid (Phase I-III)

Monte Rosa Therapeutics; Boston (MA); Hybrid; USD 70,000 - 110,000; Full time

Job summary

Monte Rosa Therapeutics is seeking a Clinical Research Associate to monitor sites, manage vendor relationships, and ensure GCP compliance across Phase I–III oncology trials. The role supports startup, data oversight, and regulatory activities, with a strong emphasis on on-site monitoring at the Boston office and a hybrid work arrangement.

The candidate will oversee CROs, perform SDV/SDR, and ensure timely study milestones while maintaining regulatory documentation and TMF quality.

Qualifications

• Bachelor's degree in life sciences, nursing, pharmacy, or related field.
• 4+ years of clinical monitoring experience, including at least 1 year on-site CRA.
• Experience with sponsor oversight of CROs/third-party monitoring vendors.
• Strong knowledge of ICH GCP, FDA regulations.
• Hands-on experience with EDC, CTMS, and eTMF systems; Medidata Rave strongly preferred.

Responsibilities

• Oversee CRO and vendor monitoring performance, including KPIs, monitoring quality, timelines, site risk, deviations, and CAPAs.
• Review monitoring visit reports and ensure findings and follow-up actions are documented and resolved.
• Conduct co-monitoring, for-cause, qualification, initiation, routine monitoring, and close-out visits as required.
• Perform SDV, SDR, remote monitoring, data review, query management, and data cleaning.
• Monitor site compliance with protocols, ICH GCP, FDA regulations, and applicable local requirements.
• Track and resolve site issues, protocol deviations, and CAPAs.
• Maintain and quality-check TMF and regulatory documents; support IRB/IEC submissions and renewals.
• Coordinate study startup activities, including feasibility, site selection, contracts, budgets, regulatory approvals, and site activation.
• Support investigator/site training, investigator meetings, data cuts, and study close-out activities.
• Maintain CTMS, EDC, eTMF, KPI, KRI, and risk-based monitoring tools.
• Collaborate with Clinical Operations, Regulatory, Data Management, Biostatistics, Pharmacovigilance, CROs, and clinical sites.
• Contribute to CSRs, regulatory submissions, study reports, dashboards, and vendor performance assessments.

Skills

Site monitoring

CRO oversight

Regulatory compliance

Education

Bachelor’s degree in life sciences, nursing, pharmacy, or related field

Tools

Medidata Rave

EDC

CTMS

eTMF

Job description

Monte Rosa Therapeutics is seeking a Clinical Research Associate to monitor sites, manage vendor relationships, and ensure GCP compliance across Phase I–III oncology trials. The role supports startup, data oversight, and regulatory activities, with a strong emphasis on on-site monitoring at the Boston office and a hybrid work arrangement.

The candidate will oversee CROs, perform SDV/SDR, and ensure timely study milestones while maintaining regulatory documentation and TMF quality.