Senior Contract Administrator

City of Hope

1d

About The Position

Join the forefront of groundbreaking research at the Beckman Research Institute of City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research.
We are looking for a Senior Contract Administrator who will coordinate and oversee the contract management of clinical trials. You will be responsible for managing, reviewing, and negotiating contracts with entities sponsoring clinical research, which include but are not limited to confidential disclosure agreements (CDA), clinical trial agreements (CTA), master service agreements (MSA), and sub-site agreements. You will be charged with developing mutually beneficial relationships with sponsors while working toward the successful and timely execution of applicable contract-related documents.
You will work in conjunction with the Office of General Counsel to develop and negotiate contractual language on behalf of the institution as well as the Budget Administrator to obtain finalized clinical trial budgets. You will also provide day-to-day administrative management support to Principal Investigators and their research teams, departmental business managers, and other stakeholders in resolving contract issues.
The position includes the general development and ongoing refinement of administrative infrastructure for the management of financial and contractual activity associated with for-profit corporate sponsorship as well as non-industry submissions pertaining to clinical trials. It will also integrate diverse elements of clinical trial management and requires creativity, teamwork and collegiality to develop and maintain sound fiscal and related administrative systems.

Requirements

• Bachelor’s Degree or equivalent combination of education and experience.
• Five years of experience working in research administration, a Contract Research Organization, pharma or biotech industry, a medical or clinical practice arena, or health insurance industry
• Must have working knowledge of clinical trials and contract development / negotiation
• Knowledge of medical terminology
• Knowledge of Good Clinical Practice Guidelines, ICH Guidelines, FDA and HIPAA regulations
• Knowledge of common contractual negotiating points such as indemnification, intellectual property, patient safety, confidentiality, billing, publication, etc.

Responsibilities

• Utilize subject matter expertise and guidance from the Office of General Counsel to negotiate contracts with clinical trial sponsors.
• Negotiate clinical trial costs that typically contain total per patient costs, start-up / administrative fees, indirect costs and payment schedule based on work completed by a third-party coverage analysis and budget developer.
• Analyze new contracts or confidential disclosure agreements received from sponsors, internal committees, or PI/study team office and determine if language conforms to institutional policy.
• Carry out periodic review of study files to ensure administrative quality, compliance and consistency across clinical trials.
• Review protocol amendments for revisions affecting the budget and/or contract.
• Track all relevant data metrics and participate in the development of new data systems and tools for electronic administration of clinical trials, including financing and documentation, at City of Hope.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees