As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.
At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.
At PRA, borders do not create boundaries. PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 14,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.
The Clinical Trials Associate assists the Clinical Project Managers in the conduct of trials and may be responsible for
managing startup activities, vendor communication or other project activities as assigned. He/She performs work within
established protocols under general supervision.
-Assists with preparation of all external and internal documentation, for assigned trials, to ensure such
documentation is completed in accordance with GCP regulatory requirements and is consistent with the study
protocol, under close supervision
-Assists Clinical Project Manager in site management activities which could include review of monitoring report,
tracking of site visits, communication with monitors and sites, and other activities as assigned
- Maintains and tracks revisions to all documentation for accuracy, including patient Informed Consent Forms and
Case Report Forms
- Assists the Clinical Project Manager in ensuring compliance with Clinical Study Protocol and provides timely
updates to assigned Clinical Project Manager to confirm compliance
- Organizes and prepares study files related to study tracking and reporting and submits them to the Trial Master File
within established guidelines
- May participate in the training of CRO teams, investigators and staff as needed regarding assigned logistics of the
- Tracks delivery and receipt of required supplies and materials to study sites and provides regular status updates
- May mentor more junior Clinical Operations Staff or participate in the on boarding of new personnel
- Performs other duties as assigned
TECHNICAL AND COMMUNICATIVE SKILLS:
�� Demonstrates a working knowledge of ICH GCP regulations and clinical protocols
�� Exhibits ability to ‘multi-task’ effectively
�� Ability to interact well with various team members and provide value added support to project.
�� Displays ability to independently solve routine problems following standard policies/procedures
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.