Vacancy expired!
Purpose:Under the direction of the Contract Administrator, is responsible to support the negotiation, execution, and oversight of sponsored program agreements/submissions, including clinical trials and grant submissions throughout UPMC. Responsible for supporting all sponsored program related activities, working collaboratively with the UPMC departments, centers, institutions, compliance offices, central administrative offices, corporate legal, outside customers and other departments as necessary. Provides vision in planning by setting measurable goals and complying with all new and ongoing processes and peripheral sponsored program activities and compliance under the direction of the Contract Administrator. This is a highly visible position that interacts with all UPMC business units at all levels of the organization.Responsibilities:
Functions as a resource person for individuals at all levels of the organization to assure timely execution and effective oversight for all sponsored programs at UPMC. This includes facilitating adherence to all UPMC requirements associated with such execution and clinical trial implementation. Due to the high level of confidentiality required by this position, extreme tact and good judgment must be exercised. This individual will have primary areas of responsibility, such as Submission, Negotiation and Execution, Contractual and Programmatic Oversight, inclusive research integrity, conflict of interest, and other external regulatory requirements.Assist the Contract Administrator with the development and implementation of Sponsored Program processes and programs. Work collaboratively to develop internal and external policies, procedures, and practices to be implemented across the organization.Report on and analyze significant changes in contractual terms impacting the clinical trials agreements.Assist the Contracts Administrator with existing master agreements to ascertain the effectiveness of automatic renewal and termination provisions, and ensure the sponsored companies are notified timely regarding master agreement that will be coming up for renewal.Review the Conflict of Interest process for all clinical trial submissions.Work collaboratively with the Contracts Administrator to assess the proper review and approval for the type of miscellaneous agreement.Work collaboratively with Clinical Trials Manager to develop training materials and perform ongoing training throughout UPMC, including the development of computer based module training.Develop, implement, and coordinate programs that focus on those elements of the system-wide research compliance program. Coordinate and facilitate program activities in order to achieve compliance with sponsor and contractual established deadlines.
Review and monitor adherence to research compliance policies and procedures. Effectively collaborate with Legal to timely and effectively handle submissions and negotiate sponsored agreements throughout UPMC for each including affected departments/centers, and respective management.Effectively communicate and support the UPMC mission and values to employees at all levels of the health system.Provide ongoing advice and resources to management for sponsored program issues and process monitoring and improvement, and work with management to implement these improvements. Research and provide follow up advice related to clinical trial related questions.Maintain a working knowledge of the various laws, regulations and industry guidance that impact the corporate research compliance program.Facilitate increased awareness of the sponsored programs by providing support of and value to management's efforts, as well as lead efforts to establish a strong, compliant education program for the research community.Participate in developing responses to external audit response to various federal agencies. Actively matrix with departmental management team and staff.Performs in accordance with system-wide competencies/behaviors.Performs other duties as assigned.
Bachelor's degree and 6 years or work experience in contract, program, or compliance management related areas such as legal, regulatory review, research, and reporting.
Experience in an academic medical center preferred.Licensure, Certifications, and Clearances:UPMC is an Equal Opportunity Employer/Disability/Veteran
Vacancy expired!