Clinical Resarch Associate In-House I&I

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

The Clinical Research Associate (CRA) supports clinical trial quality, compliance, and execution through site monitoring, study startup, data oversight, and regulatory documentation. The CRA will also serve as an in-house sponsor representative overseeing CROs and third-party monitoring vendors, ensuring delegated activities meet protocol, GCP, quality, and timeline requirements. This role will be supporting Phase I-III clinical trials , the ideal candidate will have experience in Oncology indications or I &I. The CRA will have the ability to work Hybrid work arrangement with Boston office MRTx requires a 70% office presence. .Availability for approximately 30–40% travel is required for site visits, co-monitoring, investigator meetings, and select international activities.

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.

Qualifications:

• Bachelor’s degree in life sciences, nursing, pharmacy, or related field.
• 4+ years of clinical monitoring experience, including at least 1 year of on-site CRA experience.
• Experience with sponsor oversight of CROs/third-party monitoring vendors, including KPI and performance management.
• 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%.
• Oncology clinical trial experience, particularly solid tumor or hematologic malignancies.
• Familiarity with RECIST 1.1 or other oncology endpoints.
• Experience with KPI dashboards and risk-based monitoring.
• SoCRA/CCRA or ACRP certification.
• Ability to work Hybrid work arrangement with Boston office 70% office presence.
• Availability for approximately 30–40% travel is required for site visits, co-monitoring, investigator meetings, and select international activities.

Monte Rosa Therapeutics (MRT) is a clinical-stage biotechnology company developing highly selective molecular glue degrader (MGD) medicines for patients living with serious diseases in the areas of oncology, autoimmune and inflammatory diseases, and more. MGDs are small molecule protein degraders that have the potential to treat many diseases that other modalities, including other degraders, cannot. Monte Rosa’s QuEEN (Quantitative and Engineered Elimination of Neosubstrates) discovery engine combines AI-guided chemistry, diverse chemical libraries, structural biology, and proteomics to identify degradable protein targets and rationally design MGDs with unprecedented selectivity. The QuEEN discovery engine enables access to a wide-ranging and differentiated target space of well-validated biology across multiple therapeutic areas. Monte Rosa has developed the industry’s leading pipeline of MGDs, which spans oncology, autoimmune and inflammatory disease and beyond, and has a strategic collaboration with Roche to discover and develop MGDs against targets in cancer and neurological diseases previously considered impossible to drug.