Site Activation Partner
- 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 pharmaceutical clients, with the support of PRA right behind you, you’ll be at the heart of our client’s innovation.
The Site Activation Partner is responsible for supporting operational activities related to site evaluation, activation, initiation, monitoring and close out for assigned investigator sites/studies to ensure compliance with study timelines and GCP standards. Specific tasks for this role will include:
- Completion of critical information for site activation including Investigator Initiation Packages (IIP), confidentiality agreements, study contracts, clinical supply shipment information, payment information, IRB submission and status
- Support local IRB workflow from submission through approval and support reporting of updates to safety information
- Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572 revisions, for internal regulatory approval within required timelines
- Assist with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information as needed
- As required conduct or oversee investigator site activation activities including site budget and contract negotiation and facilitate site payments
- May conduct remote monitoring activities, with a focus on Trial Master File/Site Master File reconciliation, investigational product reconciliation or other technical or logistical supportive activities that facilitate inspection readiness.
A disciplined and methodical worker, experienced in clinical site management and study activation.
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:
- Experience in study activation and site management from a pharmaceutical / biotechnology or CRO environment.
- Demonstrated knowledge of global and local regulatory requirements
- Demonstrated understanding of key operational elements of a clinical trial (e.g., study start-up, conduct, close-out activities, reporting, etc.)
- Fluent in English, and the regulatory language of the appointed location
- Proven ability to work independently and, also as a team member
- Ability to organize tasks, time and priorities, ability to multi-task
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
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
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