OverviewThe 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.
