SCOPE OF RESPONSIBILITIES
Sends CTA templates to sites, including all site/third party facilities, where applicable
Coordinates and facilitates the review and negotiation of CTAs by routing them between PSI Legal and the site, copying the responsible CRA
Timely follows up with sites on contract review status and provides feedback to the project team and PSI Legal on a regular basis. Tracks each step of the process in PRIMA.
Upon final CTA negotiation, prepares the executable version of the CTA:
Obtains final, approved budget, if necessary getting the confirmation from the Project Manager
Cross-references and fills any blanks (e.g. protocol name/number), checking site-specific information (site address, names of parties and signatories)
Checks and corrects formatting, page and paragraph numbering, etc.
Facilitates CTA execution by routing the executable CTA between PSI, site and sponsor/third party, if applicable
Files the executed CTAs in ePMF
Facilitates and documents all necessary tracking of the CTA throughout the negotiation process in PRIMA
Handles the same tasks, to the extent required, for CDAs, LOls and CTA amendments Qualifications
University degree or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities.
A minimum of 2 yearS previous experience in the clinical research industry that provides the qualifications, knowledge, skills, and abilities to perform the job
Knowledge and experience with CDAs, CTAs, LOls and CTA amendments
All your information will be kept confidential according to EEO guidelines.