Legal Support for Life Science Industry
Only freelancers located in the U.S. may apply.U.S. located freelancers only
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 determinedHourly
- 6+ monthsDuration
- IntermediateExperience Level
$50.00
-
$100.00
Hourly- Remote Job
- Ongoing projectProject Type
Skills and Expertise
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
- United States2:09 AM
- Mid-sized company (10-99 people)
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