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Covance FSP - Senior Clinical Research Associate - Cardiology - Northeast Region in BOSTON, Massachusetts

Job Overview:

Discover new opportunities to grow your career as a Covance FSP Clinical Research Associate.

At Covance, you can redefine what is possible and discover your extraordinary potential within our Functional Service Provider team (FSP). We are seeking a Senior CRA in the Northeast Region of the US to join our fully dedicated sponsor, working from a home office.

You will enjoy the best of both worlds—all the benefits that come along with Covance’s Energizing Purpose, Exceptional People and Extraordinary Potential combined with working exclusively with one sponsor using their systems and processes. This also comes with the benefit of bringing your strong therapeutic experience to a single protocol or sponsor portfolio.

Covance’s FSP model is flexible and scalable. Our teams are collaborative and proactive – a great place for you to continue honing your therapeutic skills and growing and excelling in new exciting research.

Essential Job Duties:

  • Responsible for all aspects of study site monitoring and management including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned

  • Organize and make presentations at Investigator Meetings

  • Participate in the development of protocols and Case Report Forms as assigned

  • Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned

  • Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned

  • Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management

Education/Qualifications:

  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution

  • A minimum of 3 years of Clinical Monitoring experience

In lieu of the above education requirement, candidates with a minimum of 6 years recent clinical monitoring experience will be considered.

Experience:

  • Valid Driver’s License

  • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries

  • Thorough understanding of the drug development process

For this particular client and therapeutic area, we use a risk based monitoring approach for most of our protocols. CRAs for this assignment are considered Site Managers so the algorithm is less sites per CRA. On average, CRAs will have 4-6 sites. This varies and is dependent upon enrollment, protocol difficulty, etc.

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.

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