Clinical Research Associate

3 days ago

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ProTrials Research Inc.

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Experienced Professionals, Trusted Partners Worldwide

CRO management services • Clinical Monitoring • Clinical Project Management • Clinical Site Management • Clinical Study Start-up

51 - 200

Description

• Monitoring clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit. This may include the following site visits: qualification, initiation, interim, and close out • Managing and training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion • Managing, preparing, sending, tracking, and returning investigational supplies at individual sites • Monitoring and documenting investigational product dispensing, inventory, and reconciliation • Monitoring and documenting laboratory sample storage and shipment • Monitoring trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities • Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues • Reviewing data queries and listings, and working with the study centers to resolve data discrepancies • Reviewing regulatory documentation for accuracy and completeness, and supporting study centers with regulatory issues • Maintaining complete and accurate study files and reviewing files to ensure all appropriate documentation is present • Maintaining consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials. • Following Good Documentation Practices, completing Visit Reports and site correspondence in accordance with SOPs

Requirements

• Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training • 2 years of prior experience as a Clinical Research Associate preferred • 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 medical and pharmaceutical industry, 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 • A valid driver's license with access to a car with up-to-date car insurance • Computer proficiency in Microsoft Word, Excel, and PowerPoint

Benefits

• Competitive pay • Career growth • Full medical, dental, and vision benefit packages • 401(k) with match • Commuter benefits • Legal benefits • The best coworkers, if we do say so ourselves