Manager, Contract Administration

About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 5,000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.

Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation's 20 leading cancer centers that develops and institutes standards of care for cancer treatment.

Description

The Senior Contract Administrator (SCA) is responsible for leading the contract management and negotiation of pharmaceutical, federal and foundation clinical trials. S/he is responsible for composing, 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), material transfer agreements and sub-site agreements. S/he is responsible for drafting policies and procedures that expedite the contract negotiation process and enable CoH to be a premier comprehensive cancer center. It is expected that the candidate will compose contractual language that is beneficial to CoH and will discuss all exceptions with the Senior Vice President, Research Operations, S/he is charged with developing mutually beneficial relationships with sponsors while working toward the successful and timely execution of applicable contract-related documents.

The candidate specifically works in tandem with the Office of General Counsel, Office of Technology Licensing, Compliance (as necessary) and the Senior Vice President of Research Operations to develop and negotiate contractual language on behalf of the institution. In addition, the Senior Contract Administrator (SCA) works in conjunction with the Budget Administrators to obtain finalized clinical trial budgets to include as part of the contract negotiation. S/he will review and approve all clinical research budgets, addresses concerns as necessary, develops contractual budget exhibits, and negotiates costs with the project sponsor on behalf of the institution. S/he provides day-to-day oversight of this function within overall operational and administrative management support to Principal Investigators and their research teams, departmental business managers, department business directors, 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.

The position integrates diverse elements of clinical trial management and requires creativity, teamwork and collegiality to develop and maintain sound fiscal and related administrative systems.

Essential Functions:

  • Manages Contract Administration staff to ensure workflow coordination within the department and with other departments that review and process confidential disclosure agreements (CDA), clinical trial agreements (CTA), master service agreements (MSA), material transfer agreements and sub-site agreements. Serves as contractual liaison between COH and pharmaceutical companies, foundations, NIH and other academic sites. Negotiates budget costs and provisions on all contracts. Identifies and resolves problems and issues relating to review, negotiation and administration of contracts. Provide routine status updates to Principal Investigators regarding budget and contract negotiations. Prepare presentations on status and study activation timelines to the multidisciplinary disease teams.
  • In partnership with the Office of General Counsel, Office of Technology Licensing and the Senior Vice President of Research Operations, utilizes subject matter expertise and guidance to negotiate contracts with clinical trial sponsors. Coordinate with all relevant groups to develop fully executed contracts and enhance clinical project timelines.
  • 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. Interact with sponsor officials in solving budget and contract issues such as overall trial costs, target patient accrual changes, requests for additional funds, alterations to project leadership, project location (e.g., new investigators appointed to City of Hope), etc.
  • Analyze, review and negotiate new contracts, master service agreements (MSA), Material Transfer Agreements (MTA's) or confidential disclosure agreements (CDA's) received from sponsor, 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. Work in partnership with the clinical Trials Office to update leadership on activation timelines., with special emphasis on site initiation visits. Review protocol amendments for revisions affecting the budget and/or contract. Renegotiate with sponsor, if applicable. Assist with ongoing review of internal processes to streamline roles and responsibilities; execute process changes or identify resources to accomplish projects and oversee to completion. Prepare reports and advise on feasibility and cost effectiveness.
    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. Participate on administrative committees as requested to improve the administrative understanding and support of clinical trials. Represent City of Hope at national and regional professional meetings as necessary. Maintain general knowledge of research subjects, medicare coverage guidelines and research personnel protections. Conduct special projects and perform additional duties as assigned by the Director and the Senior Vice President, Research Operations

Minimum Education: Bacherlor's degree and Juris Doctorate required

Minimum Experience: Seven plus years of experience working in research administration, a Contract Research Organization, pharma or biotech industry, a medical or clinical practice or health insurance industry

Required Courses/Training: Must have working knowledge of clinical trials and contract development / negotiation.

Preferred Courses/Training: Medical terminology a plus.

Preferred Experience: Experience in managing professionals and clerical and project support staff.

Skills/Abilities: Display tact/courtesy in dealing with faculty stakeholders, external sponsors and COH employees under a variety of situations.

Thorough experience with clear organization of documentation for negotiation and audit purposes of external contracts.

Software: Windows, Excel, Word, PowerPoint, Web- based file management.

City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.


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