PRA Health Sciences

Site Activation Partner

Location
Italy (IT)
Salary
Competitive
Posted
22 Feb 2021
Closes
24 Mar 2021
Ref
DH2020-70639
Hours
Full Time
Contract Type
Permanent
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.

You are:

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.

Apply for Site Activation Partner

Already uploaded your CV? Sign in to apply instantly

Apply

Upload from your computer

Or import from cloud storage

Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB


4000 characters left

Marketing Communication

We'd love to send you information about Jobs and Services from PharmiWeb.jobs by email.

All emails will contain a link in the footer to enable you to unsubscribe at any time.


When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on PharmiWeb.jobs you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.