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:
|
|
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.
|
|
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.
Similar Positions
-
Contract & Grant Officer, University of California Los Angeles, United States, 10 days ago
Details Posted: 09-Apr-24 Location: Los Angeles, California Salary: Open Internal Number: 1623 Department Summary OCGA is a part of the Office of Research Administration (ORA), the central institu...
-
Clinical Research Budget Coordinator I Emergency Medicine (Full Time, On Site), Cedars Sinai Medical Center, United States, 3 days ago
Come join our team! The Clinical Research Budget Coordinator I develops clinical trial budgets for industry, National Institutes of Health (NIH), and investigator-initiated clinical research. Eval...
-
Senior Contract & Grant Officer, University of California Los Angeles, United States, 10 days ago
Details Posted: 09-Apr-24 Location: Los Angeles, California Salary: Open Internal Number: 1690 Special Instructions to Applicants Please upload cover letter and resume combined Department Summary...
-
Associate Dean For Clinical Research Keck School Of Medicine Of Usc, University of Southern California, United States, 1 day ago
The University of Southern California (USC), founded in 1880, is the largest private employer in the City of Los Angeles. As an employee of USC, you will be a part of a world-class research univer...
-
Assistant Director, Clinical Research Operations, University of Southern California, United States, 11 days ago
The USC Norris Comprehensive Cancer Center’s Clinical Investigations Support Office (CISO) is seeking an Assistant Director, Clinical Research Operations to join its team. Job Summary: Provides ov...
-
Manager, Ambulatory Care Management Value Based Service Organization Full Time 8 Hour Days (Exempt) (Non Union) , University of Southern California, United States, 17 days ago
The Manager of Ambulatory Care Mgmt. provides operational support to the Ambulatory Care Management Department to ensure compliance with program requirements. The Manager of Ambulatory Care Manage...