Here at Syneos Health we are currently recruiting for a (Sr) Clinical Research Associate to be based in Germany and work on a sponsor-dedicated role.
Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.
The Clinical Research Associate performs routine site visits to ensure that the rights and well being of human subjects are protected. Additionally, the Clinical Research Associate assists in training and mentoring other regional monitoring personnel. In doing this, the Clinical Research Associate represents Syneos Health and the sponsor to site personnel and colleagues with professionalism and integrity.
This position requires monitoring visits to sites. Candidates with a varied therapeutic area background are encouraged to apply.
- Closeout visits, to include monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements, and assurance of good site performance.
- Document each visit with a quality written monitoring visit report and submit to the reviewer for review and approval within contractual guidelines.
- Author and send follow up letter to investigative site documenting the visit and any outstanding items to be addressed within contractual timelines.
- Create monitoring visit reports ensuring finalization within contractual obligations.
- Participate in feasibility studies.
- Present study materials at Investigator/study launch meetings when required.
- Perform necessary administrative functions (e.g. submission of expense reports, entering time).
- TrainMentor junior CRAs on monitoring, internal procedures, and query resolution.
- Perform regulatory activities, if applicable.
The ideal candidate will need the following experience / skills to be considered:
- Min. 2 years of the clinical monitoring experience
- Very good knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Demonstrated proficiency in problem solving, juggling multiple priorities and a commitment to quality and customer focus
- Proven ability to work independently in a fast-paced environment
- Strong communication, interpersonal, and organizational skills.
- Must demonstrate good computer skills
- Ability to provide clear direction and guidance to others
- Position requires approximately 60% travel (up to 80% during peak times)
- Fluency in German and a high level of English language are required