PRA International is one of the world's leading global clinical research organizations, conducting clinical trials in 65 countries across six continents. PRA provides outsourced clinical services across all phases of pharmaceutical and biotech drug development. Through its 30+ years of experience, PRA has developed the operational and therapeutic expertise to provide high quality, global service while maintaining our differentiating PERSONAL ELEMENT of commitment to excellence.
We currently have multiple openings for Regional CRA IIs to join our team in the therapeutic areas of oncology, CNS, musculoskeletal and infectious disease. Regional CRAs are responsible for monitoring the progress of clinical studies at investigative sites, and ensuring that clinical studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
ACCOUNTABILITIES
• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH guidelines
o Visits sites to assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the proper conduct of studies, to review data and ensure accuracy of data collected and to terminate studies
o Provides regular clinical status information to team members and project management
o Performs billable work in accordance with PRA policies, procedures, and Standard Operating Procedures
o Works closely with other team members to ensure timely resolution of project and/or clinical issues and obtains direction from more senior clinical operations staff.
o Communicates common site trends to Lead CRA and other project team members
• Performs investigative site file reconciliation; requests any new or updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements
o Performs source document verification, retrieves Case Report Forms (CRFs) and performs query resolution in a timely manner and oversees drug accountability and safety at investigative sites
o Ensures Serious Adverse Event (SAE) reporting according to project specifications
o Responds to requests from investigative sites in a timely fashion
• Mentors junior level CRAs and serves as a resource for new employees
• May serve as a resource for and interact with other functional areas to resolve site issues and facilitate project timelines
• If assigned direct reports: Schedules and reviews project tasks, provides leadership in the delivery of services to clients, ensures that staff fulfill their responsibilities in accordance with PRA’s policies, procedures, and SOPs, and ensures HR processes are properly implemented
• May be assigned Lead CRA accountabilities on non-global studies
Qualified candidates will possess:
• Undergraduate degree in a clinical, scientific, or related field or its international equivalent, or equivalent work experience required
• An advanced degree (e.g., M.S., M.B.A., PharmD, etc) preferred
• Read, write and speak fluent English; fluent in host country language
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail preferred
• Knowledge of ICH and local regulatory authority regulations regarding drug research and development required
• 18 months of field monitoring experience required in at least one of the following therapeutic areas: CNS - Musculoskeletal and Schedule II, Oncology, Infectious Disease
PRA provides its employees with an environment that fosters a sense of continuity, security, and support. This type of environment supports the high quality of our work. PRA also instills a culture that creates opportunities for employees to determine their own pathways for success.
We employ highly motivated and talented professionals to ensure the delivery of quality and reliable services that our clients expect. Through the efforts and commitment of our employees, we have created a tradition of excellence in providing drug development services worldwide. If you have the skill set outlined above, and would like to become a valuable part of our team, we invite you to apply. Qualified applicants will be contacted.
