Clinical Research Associate Medical Services
- 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 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 medical devices clients, with the support of PRA right behind you, you’ll be at the heart of our client’s innovation.
Working fully embedded within one of our clients in medical devices, with the support of PRA right behind you, you'll be at the heart of our client's innovation. As Clinical Research Associate, you will be dedicated to one of our global clients; a well-established company active in Medical Devices.
As a Clinical Research Associate, you will have the opportunity to experience the full lifecycle of a project.
The tasks undertaken by a CRA are varied and can include:
- Ensure the clinical studies are conducted according to procedures including up to date and complete trial master files, regular review of data, and assurance that monitoring reports are completed within two weeks of visit date.
- Ensure that monitoring plans are created and followed with monitoring documentation to support this included in the applicable Trial Master Files.
- Act as Clinical Study Manager for designated clinical studies under the guidance of your Manager and may support other studies in this role as applicable.
- Attend all required meetings and provide updates to team.
- Support EDC user acceptance testing and training as applicable.
- Oversee and support the creation of the trial master file, regulatory binder, source documents, and investigational product ordering, shipping, and associated documentation.
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:
- Bachelor or Masters in Science or Healthcare discipline.
- Approximately 5 years related experience in clinical studies (healthcare setting , CRO, medical device and/or pharmaceutical company and/or industry).
- At least 3 years of experience as a Clinical Research Associate monitoring clinical studies.
- Experience in using EDC and CTMS systems is desirable.
- Experience with direct line management of staff including hiring, training, oversight and mentoring.
- Good command of written and spoken English language.
- Excellent verbal and written communications skills.
- A demonstrated working knowledge of GCP, ICH guidelines, ISO Standards, FDA/EU regulations.
- Ability to work very accurate and thorough.
- Excellent record-keeping skills; good documentation practice..
- Flexibility in work hours and readiness to travel.
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.
For more information please visit our website: www.prahs.com
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