Clinical Research Associate (CRA), Gastroenterology
Company: Confidential
- Location: Region Zealand, Denmark
- Seniority: Senior
- Employment type: Part-time
- Posted: Yesterday
- Offer language: English
Job description
Clinical Research Associate (CRA), Gastroenterology, Denmark
Engagement: Part-time contract
Location: Denmark-based, with regular travel to sites in Jutland and Zealand
Commitment: A couple of on-site monitoring visits per month plus remote site support as needed.
Client Overview
A sponsor is conducting a complex, multi-site gastroenterology study at three university hospitals in Denmark. The study involves multiple vendors, centralized analyses, and patients with complex disease profiles.
Business Driver
The client needs an experienced CRA to step into an active study and provide continuity of monitoring and site support. Sites rely heavily on their CRA for guidance, especially during active enrollment, so the client wants a dedicated professional who can quickly become the trusted first point of contact for each site.
The Work
- Perform on-site monitoring visits (approximately two per month) across the study sites
- Serve as the primary point of contact for Principal Investigators and site staff, with the sponsor study team as back-up
- Provide responsive remote support to sites, answering questions and resolving issues, particularly during active enrollment
- Coordinate with multiple study vendors, including patient reimbursement providers and IMP depots
- Support sites with processes related to centralized analyses
- Review data and support sites in Viedoc (EDC and ePRO)
- Escalate issues and communicate study status to the sponsor team as needed
Professional Requirements: Technical Skills
- Experienced CRA with a strong background monitoring gastroenterology studies
- Experience with similar GI indications is a strong advantage
- Proven experience on complex studies involving multiple vendors (e.g., patient reimbursement providers, IMP depots)
- Hands-on familiarity with Viedoc as both EDC and ePRO
- Solid working knowledge of ICH-GCP and Danish clinical trial requirements
- Based in Denmark and able to travel regularly to sites in both Jutland and Zealand
Professional Requirements: Soft Skills
- Highly responsive and accessible, comfortable being the first point of contact for busy sites
- Collaborative and supportive in style
- Able to maintain a strong presence regardless of work location or frequency of interactions
- Proven track record of communicating, following up, and staying engaged, even when the work is episodic
- Strong organizational skills, with the ability to manage multiple sites and vendors in parallel
- Positive attitude and receptive to feedback on performance
