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Sr. Clinical Research Associate

Company: Kelly Services
Location: Durham
Posted on: April 9, 2021

Job Description:

Sr. Clinical Research AssociateJob DescriptionThe Sr. Clinical Research Associate manages study activity from site selection, start-up, to close-out with adherence to regulations, maintaining data integrity, and aligning deliverables with corporate goals. As a key contributor to the Global Clinical Operations team, this position develops and assesses SOPs, assesses processes for efficiency and compliance. This position requires the ability to be detail-oriented, organized, and productive with a keen interest in medical device and biologics research.RESPONSIBILITIES:

  • Independently manage all phases of a clinical study including protocol, CRF, and monitoring plan development, essential document management, contract execution, IRB/EC support, recruitment, site payment reconciliation and development of site tools.
  • Conducts Qualification, Site Initiation, Interim, and Close-Out monitoring visits to ensure adherence to monitoring plan, protocol, and regulations.
  • Train site personnel regarding the protocol and applicable regulatory requirements.
  • Ensure each site is meeting its goals of follow-up rate, data clean deadlines, protocol compliance, and enrollment.
  • Lead study meetings to ensure completion of established project team goals and objectives, including study training and data review.
  • Facilitate corrective action assessment and maintain TMF in BIMO readiness.
  • Provide study status updates to Management team and develop sufficient resolution of identified action items.
  • Contribute to annual reports, data management, data analysis, and publication support.
  • Develop and assesses SOPs annually, as needed. Maintain current knowledge of applicable US and international clinical regulations and guidance documents.
  • Participate in department systems and development initiatives including related trainings.
  • Support investigator meetings as needed.
  • Support Protocol Deviation and Adverse Event review and reporting.
  • Maintain credentialing requirements at hospitals and clinics as needed. Complete projects and tasks consistent with corporate objectives.
  • Support the Clinical Operations team in general and with various improvement projects. Perform other duties as assigned.
  • Contribute to the company culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun.QUALIFICATIONS:
    • Bachelor's--degree preferably in natural sciences or related field, or related practical experience.
    • At least 7 years of clinical research experience, medical device experience preferred. US IDE, IND, and OUS experience desirable.
    • Ability to foresee and prevent risks and understand when to elevate issues to management and recommend corrective action.
    • Excellent time management skills.
    • Ability to recognize potential obstacles and develop solutions to resolve them with minimal consequence within set timelines or change direction if priorities are modified.
    • Ability to make critical, independent decisions and be accountable for actions within a fast-moving environment.
    • Ability to perform at high-level with limited supervision and effectively partner with team members when necessary.
    • Ability to exercise critical thinking skills in selecting methods, techniques, and evaluation criteria.
    • Proficient in Microsoft Word and Excel, and the ability to quickly learn other software tools and applications, such as Access, etc.
    • Ability to develop strong relationships with investigative sites.
    • Ability to travel approximately 20-75 to attend meetings, perform training and monitoring.--Why Kelly--?Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly--At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]]

Keywords: Kelly Services, Durham , Sr. Clinical Research Associate, Healthcare , Durham, North Carolina

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