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Sr. Clinical Research Associate

Company: Actalent
Location: Wake Forest
Posted on: March 19, 2023

Job Description:

Description:The Senior Clinical Research Associate (Sr. CRA) role is integral to driving project success. This position will perform and coordinate all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and company Standard Operating Procedures.This position requires proven monitoring skills. The Sr. CRA conducts site visits to assess site adherence to protocol and regulatory requirements as well as manages required documentation. The Sr. CRA will also be responsible for ensuring the data remains audit ready and able to pass an audit by company, the Sponsor, or a regulatory agency. Responsibilities

  • Perform all site monitoring visit activities, inclusive of all study visit types (PSV, SIV, IMV and COV)
  • Participate in the site selection process with oversight from the Clinical Team Lead role
  • Provide feedback to assist sites with resolution of detected deficiencies and corrective action needed, follow-up with sites until deficiencies are resolved
  • Contribute to the development and review of protocols, study tools, and materials as well as documentation for clinical trials
  • Provide mentoring, training, and co-monitoring of junior clinical team members
  • Develop and maintain effective working relationships with clinical sites and within company as well as ensure communication of project goals and critical requirements
  • Attend and present at meetings and conferences, including Investigator Meetings
  • Participate in the RFP process, including business development meetings
  • Participate in the Clinical Operations community at company by contributing to internal initiatives and standard operating procedures for the administration and monitoring of clinical trials
  • Perform both onsite & remote monitoring and study closure activities across multiple protocols Site Visits: 8-10 days per month. Applicants must live within a 60 minute commute of a US metropolitan airport. Additional Skills & Qualifications:
    • 5+ years of on-site monitoring experience within the CRO, pharmaceutical, or biotechnology industry
    • BA/BS, preferably in a life science, nursing, pharmacy or related field
    • Superior written and verbal communications skills
    • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology required for comprehension and execution of clinical protocol
    • Demonstrated ability to train, mentor, and lead clinical research staff
    • The ability to constructively interact directly with sponsor personnel
    • Computer literacy, including proficiency in MS Office and use of EDC systems About Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, Raleigh , Sr. Clinical Research Associate, Healthcare , Wake Forest, North Carolina

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