PRA and our employees have won numerous awards and accolades in the CRO industry. In fact, we've been awarded 2016 Top Workplaces honor by Philly.com. The Top Workplaces recognition is based solely on the results of an employee feedback survey. In addition, many of our employees have won gold, silver, and bronze medals in various categories honoring clinical research and project management.
The Regional Clinical Research Associate (CRA) completes project activities associated with monitoring functions of Phase I-IV clinical research studies. Perform investigator site management activities in adherence to all applicable regulatory guidelines and standard operating procedures (SOPs).
Performs study start-up activities related to monitoring activities.
Develops and implements innovative approaches for and participates in site recruitment, selection, and initiation activities.
Participates in CRA protocol specific training and development activities.
Develops and implements innovative approaches for the preparation and coordination of investigator meetings and participates in meeting.
Conducts site initiation visits with study site staff (train site personnel in GCP and study conduct)
Develops patient enrollment strategies with the project team and clinical trial sites.
Ensures the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines.
Ensures proper storage, dispensation and accountability of clinical trial materials.
Conducts interim monitoring visits (conducts source document verification of CRF against medical records).
Performs site management activities.
Conducts in-house monitoring activities as appropriate.
Review investigator regulatory files to ensure they are accurately maintained.
Maintains patient tracking records for assigned sites.
Conducts study site close-out visits.
Completes administrative activities as a member of the project team.
Undergraduate degree or its international equivalent in clinical, science, or health related field from an accredited institution; a licensed healthcare professional (i.e., registered nurse)
2+ years of clinical monitoring experience required Knowledge of ICH and local regulatory authority regulations regarding drug (PREFERRED)
All therapeutic experience is welcome including but not limited to: Oncology, Hematology, Respiratory, Cardiovascular, Pain, CNS, Infectious Disease, Metabolism, Vaccines, Transplant and Ophthalmology
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities
Telecommuting is allowed.
Additional Salary Information: We are very competitive and open to negotiation
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.