Senior Clinical Research Associate
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Job Description
Senior Clinical Research Associate monitoring oncology and onco-hematology clinical trials for BeOne. Managing German sites, regulatory compliance, study milestones, and junior CRA mentorship.
Responsibilities:
- Execute clinical monitoring activities at clinical trial sites in accordance with ICH guidelines, GCP, local regulations, and SOPs
- Perform site selection and evaluation and support recruitment targets
- Provide protocol and study training to assigned sites
- Conduct onsite and remote pre-study, initiation, routine monitoring, and closeout visits
- Conduct co-monitoring visits when required
- Prepare visit reports, follow-up letters, action plans, and other study documentation
- Manage site performance by tracking regulatory submissions, recruitment, CRF completion, and data query resolution
- Maintain Trial Master File and Investigator's Site File documentation and ensure inspection readiness
- Report site progress, issues, and proposed actions to Clinical Operations
- Collaborate with Country and Regional Clinical Study Managers and clinical study sites to deliver study milestones
- Facilitate compliance visits, site audits, and inspections
- Evaluate site quality and integrity and escalate GCP issues
- Identify site issues, propose corrective and preventative actions, and promote operational excellence
- Mentor junior staff and act as escalation point for site-related issues
- Review visit reports, follow up on issue resolution, and communicate significant risks and proposed actions
- Serve as a subject matter expert for clinical operations, country regulations, and monitoring activities when assigned
Requirements:
- BS in a scientific or healthcare discipline preferred
- At least 3–5 years of monitoring experience
- 5+ years of CRA monitoring experience in the pharmaceutical or CRO industry
- Equivalent combination of education, training, and experience may be considered
- Advanced knowledge of applicable clinical research regulatory requirements, including GCP and ICH guidelines
- Experience in oncology/onco-hematology trials preferred
- Excellent communication and interpersonal skills
- Ability to establish and maintain effective working relationships with coworkers, managers, and internal/external stakeholders
- Excellent organizational and problem-solving skills; ability to prioritize and multitask
- Effective time management skills
- Good command of English and German
- Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, laptop computer, and iPhone
- Willingness to travel up to 80%
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