Legal Support for Life Science Industry

Posted last week

Only freelancers located in the U.S. may apply.U.S. located freelancers only

Needs to hire 2 Freelancers
Summary

We are seeking an experienced Paralegal to support clinical research and corporate contracting activities, with a particular focus on site contracting, clinical trial agreements (CTAs), and master services agreements (MSAs) with corporate reference laboratories and other clinical research vendors. This role is well suited to a highly organized legal professional with strong contract interpretation, redlining, negotiation support, and document-management skills. Experience in clinical research, CRO/pharmaceutical contracting, diagnostics, or laboratory agreements is highly desirable. Key Responsibilities • Review and support negotiation of Clinical Trial Agreements (CTAs), Master Services Agreements (MSAs), Statements of Work (SOWs), Work Orders, and related clinical research/vendor agreements. • Review contract redlines and proposed changes from clinical sites, CROs, reference laboratories, and other counterparties. • Maintain negotiation grids, contract trackers, version histories, and other systems used to manage agreements through execution. • Identify and escalate legal, financial, regulatory, and operational risks within proposed contract language. • Review agreements for consistency among the contracting entity, SOW/Work Order, study documentation, and applicable business requirements. • Identify issues involving legal entity names, successor entities, entity continuity, authority to contract, and enforceability. • Assist with review of provisions relating to indemnification, limitation of liability, confidentiality, intellectual property, data use, privacy, subject injury, termination, and other key contractual terms. • Coordinate with attorneys and internal stakeholders when provisions require legal or business escalation. • Apply knowledge of healthcare privacy and regulatory requirements to contract review, including HIPAA, data-sharing, confidentiality, Business Associate Agreement (BAA), and de-identification considerations. • Support documentation and contract processes associated with IRB requirements, informed consent, FDA-regulated activities, and clinical research operations. • Manage a high volume of agreements and competing deadlines across multiple studies and counterparties. • Conduct targeted legal and regulatory research as needed to support contract review and negotiations. Qualifications • Bachelor's degree and/or paralegal certification preferred. • Demonstrated experience supporting attorneys or business teams with contract review, legal document analysis, drafting, or negotiation. • Strong understanding of contract structure and ability to identify inconsistencies, omissions, ambiguous provisions, and potential financial or legal exposure. • Experience working with tracked changes, redlines, document comparison tools, and contract-management workflows. • Strong organizational skills and demonstrated ability to manage multiple agreements and counterparties simultaneously. • Excellent written and verbal communication skills. • Strong attention to detail and ability to independently identify issues requiring escalation. Preferred Experience • Clinical research, pharmaceutical, biotechnology, diagnostics, CRO, or healthcare contracting experience. • Direct experience with Clinical Trial Agreements, Master Services Agreements, SOWs, Work Orders, or site/vendor agreements. • Experience with sponsor/CRO/site contracting. • Experience reviewing agreements with reference laboratories, including large commercial or academic laboratory organizations. • Familiarity with study budgets, schedules of assessments, milestone payments, and per-subject/per-visit payment structures. • Familiarity with IRB processes, informed consent, GCP, FDA-regulated environments.

  • Hours to be determined
    Hourly
  • 6+ months
    Duration
  • Intermediate
    Experience Level
  • $50.00

    -

    $100.00

    Hourly
  • Remote Job
  • Ongoing project
    Project Type
Skills and Expertise
Mandatory skills
Contract Drafting
Document Review
Activity on this job
  • Proposals:5 to 10
  • Last viewed by client:last week
  • Interviewing:
    0
  • Invites sent:
    1
  • Unanswered invites:
    1
About the client
Member since Oct 8, 2024
  • United States
    2:09 AM
  • Mid-sized company (10-99 people)

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