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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.
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
Role Details:
We are recruiting for our multi-sponsor business and are currently seeking to hire a Centralized Study Specialist with a full-time, permanent and home-based contract.
This vacancy is open for candidates based in Poland, Romania or Bulgaria.
Responsibilities include but are not limited to:
- Manage clinical systems
- Manage study documents and support eTMF management
- Maintain study databases (CTMS, IWRS, EDC etc.)
- Track and follow up with CRAs for outstanding issues
- Support in generating the study specific reports
- Assist in ensuring training compliance for study teams
- Assist in study payments (Site and Vendor)
- Follow up with CRA for resolution of the outstanding issues/action items related to assigned tasks
- Draft and send study specific reports as per the study team instructions
- Collaborate with DM, Programming team for reports and communication of data related tasks
- Generate Study Reports and perform analysis
- Perform Access management on applicable study systems
- Perform study system set up on new awarded studies
- CTMS compliance management
- Review EDC, Contract and mark line items “Ready to Pay/Screen Failure” in CTMS
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Work with PA to generate cover letter or Proforma invoice and payment batch
generation in CTMS - Perform Invoice QC and Prepare GIA as applicable
- Coordinate with CTL, PM for line item approvals and GIA approval
- Process Out of Pocket and Pass Through Expense Invoices
- Perform payment reconciliation during the study close out or on adhoc request by the study team
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To execute high quality, timely monitoring and reporting plan(s) including specialized monitoring requests
for approved protocols -
To proactively identify opportunities for process improvements and support the implementation of process
improvement activities. - To support the implementation of tools internally to enhance deliverables
- Ability to mentor and train others
- To assist in the document management (including document template creation, collection, review, processing and tracking up to eTMF filing) for all documents in the scope of agreed processes/activities or within the scope of GSDM throughout the study duration
- To assist in the preparation of new investigator submission packages for site/regulatory submission.
- To support study team for contracts and budgets activities for investigative sites
- To assist the study start up teams with tasks required for site start up activities
- To review, Support, Manage or assist in Managing the site clinical trial contracts in accordance with defined processes and timelines
Education & Qualifications
- University graduate with a life science degree or nursing background who relishes working in a fast paced environment, on complex and demanding protocols
- Existing experience in clinical development and in a similar function is needed (SSU, Central Monitor, RSM etc.)
- Demonstrated ability to plan, prioritize, organize and communicate effectively
- Demonstrated ability to pay attention to detail
- Fluent in English
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.
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