Business Operations Specialist

LabCorp Nashville, TN
operations education supervision maintenance manager iec certifications collected adapt informed consent forms material negotiation
March 13, 2023
LabCorp
Nashville, TN
FULL_TIME
Job Description


Essential Job Duties:


  • Collect, track and perform a quality review of all essential & investigator documents required for effective and compliant study site activation and maintenance

  • Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines

  • Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner

  • With guidance from line manager and experienced colleagues, adapt Informed Consent Forms and other patient facing material to country specific requirements

  • May support / assist the contract negotiation process under supervision of an experienced colleague or line manager

  • Escalate study issues appropriately and in a timely fashion

  • Update study documents when there are changes in study personnel/study amendments

  • Contribute to the preparation of submissions to IRB/IEC with appropriate supervision

  • Ensure high quality documents are filed and systems are updated on an ongoing and timely basis making Covance ready for an audit at any time

  • Undertake tasks delegated by senior team members, depending upon country and situational requirements with proper supervision

  • Perform other duties as assigned by management


Education/Qualifications/Certifications
and Licenses


Recommended:


  • Level of education preferred (if required or experience level which may be substituted for level of education).

  • Professional degree/designations/certifications/licenses legally required (i.e. RN, MD, VDM etc.).

  • University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)


Experience


Minimum Required:


  • Minimum 0 – 2 years of experience, or an equivalent combination of education and

    experience to successfully perform the key responsibilities of the job

  • Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines.

  • Demonstrated basic understanding of the clinical trial process


Labcorp is proud to be an Equal Opportunity Employer:


As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.


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