Clinical Research Associate - Outsourced to Sponsor
- Experience Level
- Experienced (non-manager)
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 life-saving 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.
As a CRA, you will be dedicated to one of our global pharmaceutical clients, a company that values performance, recognises merit and has a high focus on quality. This environment encourages innovation, individuality and embraces people that want to be a part of it.
The Clinical Research Associate is ultimately responsible for the successful management of investigator sites and monitoring activities for assigned clinical studies throughout the trial lifecycle. Key responsibilities include:
- Full ownership of investigator sites for assigned studies, with responsibility for the successful management of the site right through to close-out, in accordance with the clinical monitoring plan.
- Developing effective relationships with investigator site staff to ensure that key clinical metrics are met.
- Ensuring integrity of clinical data through an ability to sufficiently maintain site tracking records and working diligently to relevant 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.
- 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.
An experienced, ambitious self-starter looking for the opportunity to prove yourself in an embedded role at a top three pharmaceutical company.
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 experience of 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 in a life science discipline or be a licensed healthcare professional.
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.
For more information please visit our website: www.prahs.com
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.