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Labcorp

Clinical Quality Control Oversight Representative, Clinical Operations

St. Louis, MO

Clinical Quality Control Oversight Representative, Clinical Operations

Remote - USA

As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.

Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.

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Did you know?

In July 2022, Labcorp announced its intention to spin off its clinical development business as a separate public company, subject to the satisfaction of certain customary conditions. Fortrea will become the new brand identity for our Clinical Development business in connection with the spin-off, which is expected in mid-2023.

We believe that the exceptional is possible when you have the right partner, so we are looking for the right people to help build a transformative force in Clinical Development. www.fortrea.com

Why settle for one thing when you can have everything? Labcorp Drug Development gives you the best two for one opportunity for career growth. Who doesn't want twice the perks - working at one of the largest FSP CROs-and partnering with one sponsor with a dedicated therapeutic focus.

Our Energizing Purpose, Exceptional People and Extraordinary Potential combined with collaborative and proactive teams offer a great place for you to continue honing your therapeutic skills and growing and excelling in new exciting research. Our reach is global - extending to 60+ countries making us one of the largest FSP CROs. So, no matter where you are located on the globe, we have an FSP opportunity for you.

The Clinical Quality Control Oversight Representative, Clinical Operations will coordinate and perform the comprehensive Quality Control Oversight (QCO) activities of CRO managed investigative sites. As needed, may also perform site management of clinical trials.

DUTIES AND RESPONSIBILITIES

  • Oversee and evaluate CRO monitoring activities through electronic data capture (electronic diaries), patient enrollment, site monitoring, review of monitor visit reports and review of status in CRO CTMS.
  • Training and oversight of other QCO representatives including contract/third party QCO representatives.
  • Participate in CRO trainings and investigator meetings
  • Review CRO CRA and contract/third party QCO representative CVs.
  • Point of contact for CRO for QCO activities and provide guidance on issue resolution.
  • Participate in study team teleconferences with CRO as necessary, present findings from QCO visits and monitoring report review
  • Liaise with CTM and CRO to create action plans based on QCO findings to improve monitoring quality.
  • Coordination of monitoring report review and QCO visits in collaboration with the Global/Regional CTM.
  • Perform QCO of CRO Monitor Visit Reports; enter any findings on the QCO Issues/Resolution Log and follow to resolution.
  • Review QC visit reports conducted by contract/third party QCO representatives for assigned regions.
  • Ensure all issues identified by QCO representatives are entered on the QCO Issues/Resolution Log and sent at prescribed intervals to the internal Shionogi and CRO study team.
  • Conduct QCO visits at investigative sites, identify and follow-up on site action items, prepare QCO visit report.
  • Interface with investigators, study coordinators, and study personnel via telephone, written correspondence, and on-site visits.
  • Participate in targeted QC review of Trial Master File.
  • As needed perform CRA Monitoring Responsibilities for clinical studies:
  • Interface with investigators, study coordinators, and study personnel via telephone, written
  • correspondence and on-site visits.
  • Coordinate and disseminate information to site staff (i.e., study protocol, CRFs)
  • Monitor study protocol(s). Collect and review regulatory documents and perform source document verification.
  • Provide verbal reporting of any serious adverse events related to the study project.
  • Complete QC trip reports and other required forms. Provide documentation for related correspondence.

MINIMUM JOB REQUIREMENTS

  • Bachelor's degree in a relevant field; R.N. or equivalent. At least 10 years minimum experience in clinical research monitoring, preferably including knowledge of multiple therapeutic areas of relevance to assigned projects.
  • A minimum of 7 years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO, and/or healthcare setting required.
  • Analytical, negotiation, meeting management, cross-functional team, and leadership skills required as demonstrated from representation at a management level.
  • Demonstrated ability to be versatile, serve as a role model to more junior clinical staff and a willingness to teach others as evidenced by a collaborative work style.
  • Knowledge and proficiency of Microsoft Office: Word, Excel, PowerPoint
  • Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
  • Strong working knowledge of Good Clinical Practices (GCPs) and pertinent U.S. FDA Code of Federal Regulations.
  • Demonstrated ability to attend to detail, make effective presentations and work independently.
  • Ability to travel independently by air, car and/or train.
  • Willingness and ability to spend prolonged periods of time reviewing medical charts and data collection forms and utilizing a small screen laptop computer.
  • Willingness and ability to travel up to 25% of the time to investigative sites throughout the United States and occasionally internationally.

Great Benefits at Labcorp:

Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including:

  • Medical


  • Dental
  • Vision
  • Life, STD/LTD
  • 401(K)
  • Employee Stock Purchase Plan (ESPP)


  • Paid time off (PTO) or Flexible time off (FTO)
  • Company bonus where applicable

Pay Range: $105,000 - $148,600

Benefits: All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, please click here.

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement.

Client-provided location(s): St. Louis, MO, USA
Job ID: labcorp-2318488_896355324
Employment Type: Other

Perks and Benefits

  • Health and Wellness

    • Health Insurance
    • Health Reimbursement Account
    • Dental Insurance
    • Vision Insurance
    • Life Insurance
    • Short-Term Disability
    • Long-Term Disability
    • Pet Insurance
    • Mental Health Benefits
    • FSA
    • HSA
    • Fitness Subsidies
    • Virtual Fitness Classes
  • Parental Benefits

    • Fertility Benefits
    • Adoption Assistance Program
    • Family Support Resources
  • Work Flexibility

    • Remote Work Opportunities
    • Hybrid Work Opportunities
    • Flexible Work Hours
  • Vacation and Time Off

    • Paid Vacation
    • Paid Holidays
    • Personal/Sick Days
    • Leave of Absence
  • Financial and Retirement

    • 401(K) With Company Matching
    • Stock Purchase Program
    • Performance Bonus
    • Financial Counseling
  • Professional Development

    • Leadership Training Program
    • Associate or Rotational Training Program
    • Tuition Reimbursement
    • Promote From Within
    • Mentor Program
    • Shadowing Opportunities
    • Access to Online Courses
    • Lunch and Learns
  • Diversity and Inclusion

    • Diversity, Equity, and Inclusion Program
    • Employee Resource Groups (ERG)

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