PRA BRIDGE PROGRAM - PRA Health Sciences
Transcription
PRA BRIDGE PROGRAM - PRA Health Sciences
PRA BRIDGE PROGRAM To help protect patient safety and receive the highest quality data, your clinical trials require Clinical Research Associates (CRAs) who have undergone a comprehensive training program. But this requirement has become more difficult to meet in the face of the industry’s CRA shortage. PRA has actively addressed this challenge with The Bridge Program, an industry-leading, innovative training model that transitions well-qualified and motivated RNs, study coordinators, and allied health professionals into a CRA role. Clinical Operations directors, functional managers, instructors, and other leaders carefully evaluate each phase of the program so that it provides high-level, didactic training under specific guidelines, demonstrating PRA’s commitment to providing the best trained CRAs in the industry. PAT I E N T A N D C L I E N T B E N E F I T S Clients and patients benefit from Bridge CRAs’ high level of detail, conscientiousness, and dedication to quality and outstanding service. Our candidates understand the healthcare industry: they’ve worked as study coordinators, site managers, and nurses (just to name a few relevant positions). Site staff and clients will work with Bridge CRAs who are experienced healthcare professionals, knowledgeable of research, and comfortable collaborating with physicians and investigators. Through this program, we’ve proven that exposing professionals with scientific backgrounds to the correct information and tools can lead to amazing results. We often hear from clients and colleagues about the quality service our new CRAs provide every day, and one of our Bridge graduates received a US Clinical Researcher of the Year award. THE BRIDGE PROCESS I just finished a 3-day IMV co-monitoring trip with our new CRA, and I couldn’t be more pleased. She is focused, positive, and driven for results. - PRA Project Manager He is an excellent example of a CRA who takes ownership of his site and maximizes its potential through his management. - Client Project Manager PRA has developed a rigorous, highly selective 10-week training program. Out of the 300+ applications we receive, we select a limited number of candidates who must: n Submit a CV to the director of PRA Clinical Operations for screening. The CV must include significant therapeutic experience in the role of a study coordinator, RN, or allied health professional. n Pass a screening interview. n Successfully complete an interview with clinical management staff. n Make the cut in the interview wrap-up meeting. P R A H E A LT H S C I E N C E S After this initial round, we trim the pool to between 20 to 40 candidates, who then: n Attend an intensive 2-week, instructor-led CRA immersion program. n Must pass final examinations with a grade of 85% or higher. n Review all required PRA SOPs and complete additional training. M E N T O R S H I P A N D E VA L U A T I O N The second phase of The Bridge Program pairs successful candidates with veteran CRAs to learn the art and science of monitoring. Our highly trained CRA mentors provide on-the-job training, working closely and meeting weekly with the new CRAs to answer questions, identify critical best practices, and address lessons learned. Upon approval from their mentors, the Bridge CRAs independently monitor sites and patients for 90 days. After that, their functional managers conduct site visits to evaluate the CRAs’ performance and adherence to quality standards. I just wanted to tell you that I LOVE the new Bridge CRAs who were assigned to the program. They are enthusiastic team players who want to learn and do as much as possible. It is wonderful to see so much gumption! SUCCESS STORY - PRA CRA Mentor PRA was awarded a global, placebo-controlled Phase III safety and efficacy study of a gout treatment. The study, which involved 125+ sites and 200+ patients, tasked a new group of Bridge graduates with developing sites, understanding recruitment needs, and enrolling subjects. This initiative had many twists and turns, with enrollment initially falling below expectations. But the Bridge CRAs worked together, relying on their previous experiences and training to generate process improvements, detailed questions, and relationship-building strategies that helped the under-performing sites eventually meet their recruitment milestones. The PRA project manager, clinical team leaders, and the client were highly impressed with the Bridge CRAs’ ideas as well as their “energy, enthusiasm, and can-do” attitudes. NEXT STEPS For additional information, please contact PRA representative Suzanne Day ([email protected]). P R A H E A LT H S C I E N C E S C O N D U C T S C O M P R E H E N S I V E P H A S E I - I V B I O P H A R M A C E U T I C A L D R U G D E V E L O P M E N T. T O L E A R N M O R E A B O U T O U R S O L U T I O N S , P L E A S E V I S I T U S AT P R A H S . C O M O R E M A I L U S AT P R A H E A LT H S C I E N C E S @ P R A H S . C O M .