Business Operations Specialist

Employer
Labcorp Drug Development - USA
Location
Nashville, Tennessee, United States
Salary
Competitive
Start date
8 Jan 2023
Closing date
7 Feb 2023

View more

Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

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.

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

Company

Labcorp Drug Development, a leading contract research organization (CRO), 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.

Together with our clients, we support the development of innovative, life-changing treatments. We look to the future and work tirelessly to test new drugs, treatments and therapies. Labcorp supports clinical trial activity in approximately 100 countries, generating more safety and efficacy data to support drug approvals than any other company.

From our Chairman and CEO – Adam Schechter

Adam Schechter

 

Marcys career journey

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