The In House Clinical Research Associate (IHCRA) performs investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, and in-house site management activities in accordance with the Sponsor and/or PRA protocol, standard operating procedures (SOPs), ICH/GCP guidelines and all applicable regulatory requirements. At the Senior level, the IHCRA will manage and lead all activities listed above and will ensure that all activities meet Sponsor and PRA expectations and are delivered in accordance with the contract, trial protocol, ICH/GCP and applicable SOPs.
3+ years of related experience
Substantial experience using computerized information systems, electronic mail, word processing and electronic spreadsheets required.
Proven clinical research experience required.
Through knowledge of ICH and local regulatory authority drug research and development regulations required.
Achieves successful delivery of site start-up, in-house site management and close-out activities meeting internal and external client requirements.
Participates in the creation and maintenance of clinical project documents including, but not limited to Clinical Management Plans, monitoring Guidelines, Site Operations Manuals, Monitoring Visit Letter templates and Project Start-up Plans liaising with the CTM/SUL.
Determines, tracks, and reviews milestones, tasks, timelines, and project hours for all the clinical activities for assigned projects, ensuring adherence to contract and budget.
Provides timely status reports for the clinical activities on assigned projects.
Serves as primary liaison for site start-up and in-house site management issues, escalating to the SUL/CTM and/or Project Manager (PM) as required.
Ensures that all tasks meet Sponsor and PRA expectations, and are delivered in accordance with the contract, trial protocol, ICH/GCP and applicable SOPs.
Provides data as required for clinical operations performance metrics and project status metrics.
Recommends and implements enhancements to clinical systems to guarantee successful delivery.
Leads multiple IHCRAs on a project, providing training and mentoring as required
Ensures the clinical operations team is kept current on timelines, clinical activities, and contract/budget status.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
Who we are: We know that what do helps change peoples lives for the better every single day. We know that in order for clinical development to reach its full potential, our industry needs people who truly care about each and every outcome, and we know that's the reason people come to work with us. Our employees care about what we do and they care that its done better then It's done before. We kn...ow people count on us, because that is who we are. We are PRA.
PRA Health Sciences delivers innovative drug development solutions that improve patients’ lives. Our people are passionate about clinical research, working tirelessly to provide quality results for clients. We offer exceptional experience across all phases, therapeutic areas and a broad spectrum of solutions, ranging from full-service clinical development to our pioneering Embedded model.
With 11,000+ employees covering 80+ countries, we bolster an impressive global presence with keen local insights. Our project teams harness their understanding of local regulations, standards of care and cultural customs to effectively align our approaches with each study’s unique goals.
Our affiliate in China provides comprehensive clinical research services for all major territories. With 300+ staff in 15 cities and six offices in Shanghai, Beijing, Guangzhou, Wuhan and Hong Kong, our China operations offer the necessary depth of global resources and technical support to support studies of any size and scope.
At PRA, we love what do, because we are making a difference in the lives of patients and their family members worldwide. Over the years, we have contributed to the development of numerous drugs now available to countless patients. From our scientific and medical experts to therapeutically aligned project managers and monitors, we provide the commitment and expertise needed for today’s complex studies.