Overview
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.
- Phase 1/2 experience, including SAD/MAD, PK/PD, or dose-escalation studies.
- 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.
