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Lead Clinical Research Contracts Specialist (P) The candidate will negotiate and prepare clinical research study contracts that include Confidentiality Agreements, Non-Disclosure Agreements, Clinical Trial Agreements, Nonconforming Subcontracts, Master Service Agreements, Material Transfer Agreements, and Data Transfer Agreements .Will review sponsor contract language and embed client specific contract terms and verbiage as approved by client’s legal department. Current permanent U.S. work authorization is required. Legal degree (Juris Doctor) from an accredited institution is essential. Should have 5+ years of experience in clinical research contractual agreements, such as confidentiality agreements, non-disclosure agreements, clinical trial agreements, master service agreements, material transfer agreements and data transfer agreements. Knowledge of federal regulations related to clinical research, including NIH regulations covering NIH funded inventions is essential. Admission to a local state Bar Association is preferred. Working knowledge and experience with clinical trial regulatory documents such as study protocols, informed consent documents and study budgets is preferred. Knowledge of Good Clinical Practice Guidelines, ICH Guidelines, FDA and HIPAA regulations is preferred. Knowledge of common contractual negotiating points such as indemnification, intellectual property, patient safety, confidentiality, billing, and publication is preferred.
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