Senior Clinical Research Associate - Oncology
- Experience Level
- Experienced (non-manager)
We Are PRA.
PRA Health Sciences is seeking the best and brightest, nothing less will do.
We are 17,000+ employees strong, operating in more than 90+ countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most. When there is a team of 16,000 moving forward together with a common goal, given the support, tools and technology needed, that single step becomes a movement. Interested? Come join the movement and discover YOUR PRA.
As a Senior Clinical Research Associate, you will be working with a single sponsor and be a valued contributor to their drug development program. For this position, our sponsor is dedicated to the development and commercialization of innovative cancer treatments.
• 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.
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 is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
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