Senior Clinical Research Associate - Contract Position

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