PRA Health Sciences is seeking the best and brightest, nothing less will do.
Who we are: We are 11,000 employees operating in 85 countries committed to saving lives, operating in unison. We are the best at what we do and always strive to be better. We are subject matter and therapeutic experts and each realize that every big change in history has begun with a single step. The impact is real and significant, we see it every day. We are making a difference and bringing lifesaving drugs to market faster than ever before and getting them into the hands of the men, women and children who need them. When there is a team of 11,000 moving forward together with a common goal, given the support, tools and technology needed, that single step becomes a movement. Interested? Come join the movement and discover YOUR PRA.
What’s in it for you long term?
Ask our CRAs, they will tell you the following… And it’s all true.
We promote from within – We provide a career not a job.
Culture – There is nothing like it. The proof is in the pudding with 6.5 former PRA employees returning every single month.
Tools and Technology – Leading the industry with time saving, intuitive smart technology to help predict trends, anticipate needs and eliminate the need for multiple data entry
Security – We are growing and we are dedicated to having you grow with us
Mentorship and Training – Our structure provides support for your growth and development as well as questions that arise while on a study at all times
Work Life Balance – Its real, we value it. Our strategic solutions and full service models offer you choices for finding a career that includes time for your personal life
We are committed to providing our employees with a competitive salary and benefits package with yearly merit and performance reviews
The Clinical Research Associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
Undergraduate degree not required but need to have 5 years of home based monitoring experience
3+ 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
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.
Bachelor’s Degree in allied health fields such as Nursing, Pharmacy, or Health Science
Minimum of 4 years of clinical research monitoring experience
Experience working with multiple protocols within multiple TAs is required
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.