Clinical Research Associate
hace 4 horas
Job Summary:
The Clinical Research Associate (CRA) is a key member of the Merck Gruppe - MSD Sharp & Dohme team, responsible for ensuring the successful conduct of clinical trials in assigned countries. As a CRA, you will be accountable for performance and compliance for assigned protocols and sites, ensuring that all study conduct is in accordance with ICH/GCP and country regulations, company policies and procedures, quality standards, and adverse event reporting requirements.
Key Responsibilities:
- Develop and maintain strong site relationships, ensuring continuity of site relationships throughout all phases of the trial.
- Perform clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents.
- Gain an in-depth understanding of the study protocol and related procedures, coordinating and managing various tasks in collaboration with other sponsor roles to achieve Site Ready.
- Participate in site selection and validation activities, performing remote and on-site monitoring & oversight activities using various tools to ensure data integrity, subject rights, safety, and well-being.
- Conduct site visits, including validation visits, initiation visits, monitoring visits, close-out visits, and record clear, comprehensive, and accurate visit & non-visit contact reports.
- Collect, review, and monitor required regulatory documentation for study start-up, study maintenance, and study close-out, communicating with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.
- Identify, assess, and resolve site performance, quality, or compliance problems, escalating as necessary in collaboration with CRA Manager, CRM, TA Head, and CRD.
- Work in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal, and regional operations, HQ functional areas, and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
- Manage and maintain information and documentation in CTMS, eTMF, and various other systems as appropriate and per timelines.
- Contribute to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor, and sharing best practices as appropriate/required.
- Support and/or lead audit/inspection activities as needed, performing co-monitoring visits where appropriate.
Requirements:
- Employee Status: Regular
- Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements:Hybrid
- Shift: Valid Driving License: Hazardous Material(s):
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