Hybrid Oncology Clinical Research Associate

Monte Rosa Therapeutics, Inc.; Boston (MA); Hybrid; USD 90,000 - 130,000; Full time

Job summary

The Clinical Research Associate at Monte Rosa Therapeutics, Inc. supports trial quality, compliance, and execution through site monitoring, study startup, data oversight, and regulatory documents.

The role serves as an in-house sponsor representative overseeing CROs and third-party monitoring vendors to ensure protocol adherence, GCP, and timelines across Phase I–III oncology studies. The ideal candidate has 4+ years of clinical monitoring experience with on-site CRA exposure, strong knowledge

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, and sponsor oversight requirements.
• Hands-on experience with EDC, CTMS, and eTMF systems; Medidata Rave strongly preferred.
• Valid driver's license and passport with ability to travel 30-40%.

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 appropriately 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 essential 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

Clinical monitoring

On-site CRA

Sponsor oversight

Education

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

Tools

Medidata Rave

EDC

CTMS

eTMF

Job description

The Clinical Research Associate at Monte Rosa Therapeutics, Inc. supports trial quality, compliance, and execution through site monitoring, study startup, data oversight, and regulatory documents.

The role serves as an in-house sponsor representative overseeing CROs and third-party monitoring vendors to ensure protocol adherence, GCP, and timelines across Phase I–III oncology studies. The ideal candidate has 4+ years of clinical monitoring experience with on-site CRA exposure, strong knowledge