Clinical Research Associate
Venn Life Sciences is an Integrated Drug Development Partner offering a unique combination of drug development expertise and clinical trial design and management. This enables us to create, plan and execute drug and medical device development programs effectively and seamlessly for our clients.
We have dedicated operations in Ireland, France, Germany, the Netherlands, the UK, the US, and European-wide representation. “Our vision is to deliver results of the highest quality to our global sponsors on time and within budget. We do this through developing our staff to be world class in their fields and forming real, lasting relationships with our clients.”
We are currently seeking a Clinical Research Associateto join our Clinical Operations Team based in Rheinbach, Germany. This role will cover all aspects of clinical monitoring and site management.
Responsibilities & Accountabilities:
- Assist team members to facilitate the successful completion of the clinical program
- Understand and adhere to ICH/GCP regulations and internal Quality Documents and processes
- Prepare/assist in Ethics Committee/Institutional Review Board (IRB) and regulatory authority submissions and follow the process until approval
- Identify, select, initiate and close-out investigational sites
- Prepare and coordinate feasibility analysis
- Mentor teams and train junior staff including co-monitoring
- Identifying training and/or process issues at the study sites
- Support the project manager as required
- Monitoring of clinical trials and other data checking activities
- Developing key study documents including informed consent forms, data management plans, case report forms, study specific SOPs, etc.
- Archiving study documentation and correspondence
- Developing and maintaining strong working relationships with site investigator and study site staff, promoting study recruitment strategies
Key Capabilities Required:
Qualifications & Experience:
- Graduate with life sciences Degree or equivalent nursing qualification
- Minimum 2 years’ experience with independent monitoring experience
- Knowledge of ICH-GCP
- Excellent communication skills (both written and oral)
- Ability to establish and maintain effective working relationships with co-workers, managers and clients
- Proactive contribution towards the team by being a flexible team player
- Ability to motivate others
- A concern for quality, attention to detail and accuracy
- Ability to multi-task and problem solve and time management
- Ability to work independently in a fast-paced environment
- Good organizational, computer and administrative skills
- Flexibility, curiosity and willingness to improve skill set (self-training)
- Prepared to travel locally and internationally would be essential
- Fluent English & German (Written & Oral) – Other language skills would be an advantage
How to apply:
Please forward your CV (in English) and motivation letter by email to Liane Brown-Feaheny, Human Resources, via email@example.com
We do not require the services of agencies for this role.
For more information on our resourcing services visit: www.vennlifesciences.com.