Executes registration and results disclosure activities in accordance with sponsor requirements and international regulations. Participates on project teams to provide guidance on public disclosure processes and requirements, including regulatory requirements for registration and results posting content and format.Executes registration and results disclosure activities in accordance with applicable international law, regulatory requirements and Sponsor policies and procedures under the supervision of the Funct. Assumes primary responsibility for assembling information, registering and maintaining registrations and posting results on clinicaltrials.gov and other applicable websites, under the direction of Associate Director. Consults with scientists from multiple functions and partners worldwide such as Clinical Operations, Statistics, Medical and Scientific Affairs, Regulatory Affairs and Medical Writing to obtain and ensure accuracy of registration and results posting. Consults directly with ClinicalTrials.gov and other government registry operations staff as needed during data submission. Notifies applicable functions of registration and results posting. Participates on relevant global project teams and task forces and consults with clinical, medical writing and statistics scientists providing guidance on public disclosure processes and requirements and information, including US and international regulatory requirements for registration and results posting content and format. Collaborates with CTR scientists located internationally to ensure consistency of disclosed clinical trial information.
5 years of relevant experience
Bachelor’s degree in relevant field of study. Master’s degree preferred.
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.