Oncology Clinical Research Associate — Hybrid (Boston)

Monte Rosa Therapeutics, Inc.; Boston (MA); Hybrid; USD 90,000 - 140,000; Full time

Job summary

Monte Rosa Therapeutics, Inc. in Boston seeks a Clinical Research Associate to support trial quality, compliance, and execution across Phase I–III oncology studies.

The CRA will monitor CROs and vendors, manage regulatory documents, and contribute to site startup, data review, and safety oversight while working in a hybrid Boston office with 70% on-site presence and travel up to 40% for site visits and meetings.

Qualifications

• Bachelor’s degree in life sciences, nursing, pharmacy, or related field.
• 4+ years of clinical monitoring experience, incl. 1 year on-site CRA.
• Experience with sponsor oversight of CROs/third-party monitoring vendors incl KPI.
• Strong knowledge of ICH GCP, FDA regulations, and sponsor oversight requirements.
• Hands-on experience with EDC, CTMS, and eTMF systems; Medidata Rave preferred.
• Valid driver’s license and passport with ability to travel 30–40%.
• Oncology trial experience, solid tumor or hematologic malignancies.
• Familiarity with RECIST 1.1 or oncology endpoints.
• Experience with KPI dashboards and risk-based monitoring.
• SoCRA/CCRA or ACRP certification.
• Hybrid work arrangement with Boston office 70% office presence.
• Availability for 30–40% travel for site visits and meetings.

Responsibilities

• Oversee CRO and vendor monitoring performance including KPIs and quality.
• Review monitoring visit reports; document findings and follow-up actions.
• Conduct co-monitoring, initiation, routine monitoring, and close-out visits.
• Perform SDV, SDR, remote monitoring, data review, queries, data cleaning.
• Monitor site compliance with protocols, ICH GCP, FDA regulations.
• Track and resolve site issues, deviations, and CAPAs.
• Maintain and quality-check TMF and regulatory documents; support IRB submissions.
• Coordinate study startup activities: feasibility, site activation, contracts, budgets.
• Support investigator/site training, investigator meetings, data cuts, close-out.
• Maintain CTMS, EDC, eTMF, KPI, KRI, and risk-based monitoring tools.
• Collaborate with Clinical Ops, Regulatory, Data Management, Biostatistics, PV, CROs, sites.
• Contribute to CSRs, regulatory submissions, study reports, dashboards, vendor assessments.

Skills

Oncology trials

KPI dashboards

Risk-based monitoring

Sponsor oversight

Travel readiness

Education

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

Tools

Medidata Rave

EDC

CTMS

eTMF

Job description

Monte Rosa Therapeutics, Inc. in Boston seeks a Clinical Research Associate to support trial quality, compliance, and execution across Phase I–III oncology studies.

The CRA will monitor CROs and vendors, manage regulatory documents, and contribute to site startup, data review, and safety oversight while working in a hybrid Boston office with 70% on-site presence and travel up to 40% for site visits and meetings.