PRA International

Clinical Research Associate (CRA) - various levels

How to Apply for this Job
Company: PRA International Contact Name: Kathy Miller Email your resume (Click Here) Use one of the above methods to apply for this job.

• Job ID:CRAaw
• Date:07/03/2008
• Location:
• State:Illinois
• Current Professional Level:Experienced Staff Level

Additional Salary/Compensation:

10% Bonus

Job Types:

Clinical Research Associate

** Midwest & Mid-Atlantic – Regional, Home-based

Monitors the progress of clinical studies at investigative sites, and ensures 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

QUALIFICATIONS • 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 preferred for CRA I; required for CRA II and III • Clinical research employment experience required for CRA II and III; preferred for CRA I • Must have at least 6 months previous experience as a monitor; previous Oncology or CNS experience highly preferred

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