ABOUT THE JOB
ProTrials is seeking a Contract Senior Clinical Research Associate to join our team.
The Contract Senior Clinical Research Associate (Sr. CRA) plays an integral part in the successful monitoring and management of clinical trials. Responsibilities of a Contract Sr. CRA include ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH GCP, and all applicable regulatory requirements. Contract Sr. CRAs may be required to travel up to 65%.
HERE IS WHAT YOU WILL DO:
Monitor clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit, including qualification, initiation, interim, and close-out site visits
Manage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion
Manage and track the preparation and return of investigational supplies at individual sites
Monitor and document investigational product dispensing, inventory, and reconciliation
Monitor and document laboratory sample storage and shipment
Monitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities
Review source data and case report forms for accuracy, completeness, and integrity of the data, and identify and resolve ongoing data issues
Review data queries and listings, and work with study centers to resolve data discrepancies
Review regulatory documentation for accuracy and completeness, and support study centers with regulatory issues
Maintain complete and accurate study files and review files to ensure all appropriate documentation is present
Maintain consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials
Serve as a resource for project team members including supporting CRA I and CRA II staff by providing solutions to resolve issues
HERE IS WHAT YOU BRING TO THE TABLE:
RN or Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training, and previous CRA experience demonstrating career growth in the CRA position
Detail-oriented
Excellent organizational skills, strong interpersonal and communications skills, and strong problem-solving skills
Flexibility with changing priorities
Ability to efficiently perform and prioritize multiple tasks
Familiarity with the medical and pharmaceutical industries, and related terminology and practices
Extensive knowledge of FDA regulations and their practical implementation
Ability to travel, including by air or by car on short notice
Proficiency in Microsoft Word, Excel, and PowerPoint
