Senior Clinical Research Associate (m/w/d)
Company: SThree Agency
- Location: Munich, Germany
- Work mode: Hybrid
- Seniority: Senior
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
Senior Clinical Research Associate (m/w/d)
Location: München / hybrid
Employment Type: Permanent / Full-time
Key Responsibilities
- Independently conduct all types of monitoring visits, including:
- Site Selection Visits (SSVs)
- Site Initiation Visits (SIVs)
- Routine Monitoring Visits
- Close-Out Visits (COVs)
- Remote Monitoring Visits
- Perform Source Data Verification (SDV), Source Data Review (SDR), and CRF review.
- Ensure timely resolution of data queries and site-related issues.
- Act as the primary point of contact for assigned investigational sites.
- Support site identification, feasibility, and activation activities.
- Maintain study documentation in compliance with ICH-GCP, local regulations, and SOPs.
- Monitor patient safety, protocol compliance, and data integrity.
- Collaborate closely with Clinical Trial Managers, Project Managers, Medical Monitors, and cross-functional study teams.
- Support and mentor less experienced CRAs where appropriate.
- Contribute to study planning, site performance management, and overall study delivery.
Qualifications
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, Medicine, or a related field.
- Independent monitoring experience within Germany.
- Experience conducting all major monitoring visit types across Phase II and/or Phase III clinical trials.
- Strong understanding of:
- ICH-GCP
- EU Clinical Trial Regulations
- Clinical trial operations and compliance requirements
- Excellent communication and stakeholder management skills.
- Ability to work independently while collaborating effectively with cross-functional teams.
- Professional proficiency in both German and English.
- Proficient in Microsoft Office applications.
- Valid driver's license and willingness to travel regularly within Germany.
Looking forward to your application.
SThree_Germany is acting as an Employment Agency in relation to this vacancy.
