Senior Contract Administrator – Clinical Trials

📋 Description

• Oversee the negotiation and implementation of clinical trial agreements, which encompass CTA, CDA, MSA, and sub-site agreements.

• Collaborate with the Office of General Counsel to formulate and finalize contract language.

• Negotiate clinical trial budgets, including costs per patient, startup fees, and payment timelines.

• Review contracts and agreements for compliance with institutional policies.

• Work alongside sponsors to address budget, contract, and study-related challenges.

• Create contract budget exhibits and assist with financial planning for studies.

• Offer continuous administrative support to Principal Investigators and research teams.

• Monitor study files to guarantee compliance, quality, and uniformity.

• Track essential contract and budget metrics, aiding in reporting and process enhancements.

• Engage in cross-functional initiatives aimed at improving clinical trial administration.

⛳️ Requirements

• Bachelor’s degree or a comparable combination of education and experience.

• J.D. is highly preferred.

• At least 5 years of experience in research administration, CRO, biotech/pharma, or the healthcare industry.

• Extensive experience with clinical trials and contract negotiation.

• Familiarity with medical terminology and clinical research processes.

• Knowledge of GCP, FDA, HIPAA, and ICH guidelines is preferred.

• Experience in negotiating critical contract terms such as indemnification, IP, and confidentiality.

• Proficient in Microsoft Office and data analysis tools.

🏝️ Benefits

• Comprehensive Benefits