Start-up Associate

hace 3 semanas

Buenos Aires, Argentina Labcorp A tiempo completo

Trial and site administration:

  • Tracking (e.g. essential documents) and reporting (e.g. Safety Reports)
  • Ensure collation and distribution of study tools and documents
  • Update clinical trial databases (CTMS) and trackers
  • Clinical supply & nonclinical supply management, in collaboration with other country roles
  • Manage Labeling requirements and coordinate/sign translation change request

Document management:

  • Prepare documents and correspondence
  • Collate, distribute/ship, and archive clinical documents
  • Assist with eTMF reconciliation
  • Updating manuals/documents (e.g., patient diaries, instructions)
  • Document proper destruction of clinical supplies.
  • Prepare Investigator trial file binders
  • Execute eTMF Quality Control Plan
  • Obtain translations of documents

Regulatory & Site Start-
Up responsibilities:

  • In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site
start-up and submissions

  • Obtain, track and update study insurance certificates
  • Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
  • Publish study results for GCTO and RA where required per local legislation

Budgeting, Agreement and Payments:

Collaborate with finance/budgeting representatives for**:

  • Develop country and site budgets (including Split site budget)
  • Tracking, and reporting of negotiations
  • Maintenance of tracking tools
  • Working knowledge of Contract development, negotiation, approval and maintenance (e.g. CTRAs)
  • Update and maintain contract templates (in cooperation with Legal Department)
  • Payment calculation and execution (investigators, vendors, grants)
  • Ensure compliance with financial procedures
  • Monitor and track adherence and disclosures
  • Budget closeout.
  • Obtain and process FCPA documentation in a timely manner

Meeting Planning:

  • Organize meetings (create & track study memos/letters/protocols)
  • Support local investigator meetings (invitations, prepare materials, select venue, support vendor where
applicable

Experience Required
Minimum 1-2 years in Clinical Research or relevant healthcare experience

Note Specific experience requirements may vary depending on the Country

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.

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