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CRA, Clinical Research Associate

Los Gatos, CA 95032

Posted: 11/14/2022 Employment Type: Direct Hire/Perm Job Number: 513784-1 Country: United States Is job remote?: Yes

Job Description

Regional CRA

SUMMARY

The CRA, Clinical Research Associate plays a vital role in the Clinical Operations team. Through responsibilities like monitoring studies, reviewing data, and engaging with sites, the CRA will ensure the success of clinical trial operations and management. ESSENTIAL DUTIES
    • 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
OTHER QUALIFICATIONS
    • 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
EDUCATION AND/OR EXPERIENCE
    • 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
PERKS AND BENEFITS
    • Competitive pay
    • Career growth
    • Full medical, dental, and vision benefit packages
    • 401(k)
    • Commuter benefits
    • Legal benefits
    • The best coworkers, if we do say so ourselves
* CO candidates may not be considered

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet domain (@theplanetgroup.com, @theplanetforward.com, @planet-technology.com, @planet-pro.com, @planetinteractive.com, @pfes.com, @launchcg.com, @planet-pharma.com, @planet-healthcare.com) - and not a domain with an alternative extension like .net, .org or .jobs.

The Planet Group and our companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Los Gatos, CA

Explore exciting job opportunities in the vibrant area around Los Gatos, California! Nestled in the scenic Santa Clara Valley, also known as Silicon Valley, this region offers a dynamic and innovative environment perfect for career growth. With proximity to tech giants like Apple and Google, Los Gatos boasts a unique blend of upscale boutiques, art galleries, and charming cafes. Enjoy the picturesque Los Gatos Creek Trail for outdoor adventures or indulge in the town's rich culinary scene. Catch a performance at the historic Villa Montalvo or attend a game at the nearby Levi's Stadium. Discover why Los Gatos is the perfect place to take the next step in your career journey. Start exploring our job listings today!
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