Business Operations Specialist
LabCorp
Nashville, TN
operations
education
supervision
maintenance
manager
iec
certifications
collected
adapt
informed consent
forms
material
negotiation
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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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