Senior Clinical Research Associate – Oncology
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Job Description
Senior Clinical Research Associate monitoring oncology clinical trials for global CRO Worldwide Clinical Trials in Germany. Leading site activities, mentoring CRAs, and ensuring GCP-compliant study delivery.
Responsibilities:
- Lead site activities across the study lifecycle, including feasibility, qualification, initiation, interim monitoring, site management, and close-out visits
- Monitor protocol adherence, patient safety, informed consent, source documentation, study data, CRFs, and investigational product accountability
- Resolve data queries with sites and maintain Investigator Site Files
- Complete regulatory and ethics documentation and provide documentation for the Trial Master File
- Coordinate CRAs as a Lead CRA on global studies
- Work with Project Management to evaluate study deliverables and milestones
- Mentor less experienced CRAs and site staff through accompanied visits, training, and guidance
- Review site visit reports and provide constructive feedback
- Contribute to Clinical Monitoring Plans, protocols, CRFs, study-specific tools, templates, and monitoring/site-management initiatives
- Collaborate in study team meetings, investigator meetings, and bid defenses
- Maintain regular communication with investigative sites, sponsors, and global study teams
Requirements:
- MD or Pharmacy degree with at least 3 years of CRA experience; or four-year degree in medical, biological, physical, health, pharmacy, or related science with at least 5 years of CRA experience; or two-year college curriculum or equivalent education/training, preferably nursing or life sciences, with at least 7 years of CRA experience
- Thorough knowledge of clinical research principles and processes, GCP, ICH Guidelines, applicable FDA and/or EU regulations and directives, local regulatory requirements, and SOPs
- Strong understanding of two to three therapeutic areas
- Excellent planning, organization, time management, communication, interpersonal, problem-solving, leadership, and mentoring skills
- Proficiency with Microsoft Office, IxRS, and EDC systems
- Proficiency in spoken and written English, together with fluency in the local language(s) of the countries under responsibility
- Valid current passport and driving license
- Must reside in Germany and be based within the territory
- Willingness and ability to travel to investigative sites approximately 6–8 days per month
Benefits:
- Collaborative and inclusive work environment
- Growth and career development opportunities
- Learning opportunities
- Home-based work arrangement
- Opportunity to contribute as a Lead CRA on global studies
- Mentoring and training opportunities
- Opportunity to help bring life-changing therapies to patients
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