Senior Contract Administrator

Location
Monrovia, California
Salary
Competitive
Posted
July 10 2021
Ref
10012253
Discipline
Life Sciences
Position Type
Full Time
Organization Type
Healthcare/Hospital
About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 6000 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 leading cancer centers that develops and institutes standards of care for cancer treatment.

Position Summary

Coordinates and oversees the contract management of clinical trials. Is 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. Is charged with developing mutually beneficial relationships with sponsors while working toward the successful and timely execution of applicable contract-related documents.

Specifically works in conjunction with the Office of General Counsel to develop and negotiate contractual language on behalf of the institution. Works in conjunction with the Budget Administrator to obtain finalized clinical trial budgets. Reviews approved budgets, addresses concerns as necessary, develops contractual budget exhibits, and negotiates costs with the project sponsor on behalf of the institution.

Provides 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.

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.

Key Responsibilities include:
  • Utilize subject matter expertise and guidance from the Office of General Counsel 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.
  • Analyze new contracts or confidential disclosure agreements received from sponsor, internal committees, or PI/study team office and determine if language conforms to institutional policy.
  • 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.
  • 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. 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.
  • Provide routine status updates to Principal Investigators regarding budget and contract negotiations.
  • 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 and research personnel protections.
  • Conduct special projects and perform additional duties as assigned by the Director.


Basic education, experience and skills required for consideration:
  • 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;
    OR
    2 years of direct clinical research experience in combination with a Juris Doctor degree


Required Certification/Licensure:
  • Must have working knowledge of clinical trials and contract development / negotiation
  • Medical terminology

Preferred education experience and skills:
  • 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.
  • Clinical trial contracting; contract / budget negotiations


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.

  • Posting Date: Jul 9, 2021
  • Job Field: Clinical Research
  • Employee Status: Regular
  • Shift: Day Job

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