Clinical Research Associate
- Experience Level
- Experienced (non-manager)
Clinical Research Associate
Providing innovative solutions for our clients is what we do. But innovation just for the sake of innovation isn’t why we do it. Side-by-side with our clients, we strive to move drug discovery forward, to help them develop lifesaving and life-improving drugs. We help change people’s lives for the better every single day. It’s who we are. And it’s who you could be too. Working fully embedded within one of our pharmaceutical clients, with the support of PRA right behind you, you’ll be at the heart of our client’s innovation.
Location: Germany, home-based
As a Clinical Research Associate, you will be dedicated to a one of our global Biotechnology clients who have an emerging presence in Europe and who are committed to improving lives of patients though innovative and transformative therapies.
The CRA is responsible for monitoring and management of clinical sites. This position focuses on all activities required to evaluate, initiate, monitor and close clinical sites in compliance with the Regulations and ICH/GCP Guidelines
· Act as liaison between the in-house team, vendors, and multiple clinical sites.
· Work collaboratively with investigative sites to develop strong, long-term, working relationships.
· Apply SOPs, Clinical Monitoring Plan (CMP), study manuals and other materials and guidelines as applicable.
· Help identify and qualify potential investigators.
· Perform all type of visits from Pre-Study to Close out.
· Provide initial and ongoing training to site personnel regarding the study protocol, applicable policies/procedures, and GCP.
· Assist with start-up activities, including essential document review and collection as requested.
· Lead and drive regulatory Ethics Committee submission and site start-up activities in partnership with investigator sites including the support of EC follow up queries and responses as required.
· Liaise with sites to support contracts/budget negotiation and support the development and adaptation of country/site specific informed consent forms under the direction of the internal team.
We believe our Clinical Operations team is second to none. You will receive the support you need to develop personally and professionally and work in an environment where you matter. Our team pushes forward together. United in solving problems, developing close site relationships and reaching the end goal. Operating as a key part of a global study team, the CRA plays a fundamental role in our clients’ drug development processes.
Detail-orientated, passionate and reliable.
Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
· Prior and solid experience as a CRA working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
· A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
· You will be educated to degree level, have equivalent experience or be a licensed healthcare professional.
· Experience in central submissions and hospital submissions as well as experience in contract negotiation.
· Experience working in oncology clinical trials.
Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
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