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Years of Experience
Date Last Verified
Contracts Administrator- Research The candidate will under the guidance and training of the Manager, will be responsible for the drafting, preparation, and negotiations of agreements in support of clinical research sponsored by industry with the Research Institute of Childrenâ€™s Hospital of Philadelphia. Additionally will: (1) interface with the Clinical Trials Financial Management (CTFM) group for budget approvals in support of industry-sponsored research; (2) maintain the departmental agreement database; (3) participate in the drafting, preparation, and negotiation of other agreements as requested; and (4) assist with development and implementation of institutional policies and procedures related to industry-sponsored research. Prepare for execution in a timely fashion and according to CHOP policies and department procedures: Clinical Trial Agreements and other agreements in support of clinical research supported by industry. Work with contracting team members, individual investigators, and CHOP personnel in the intake, negotiation, and execution of agreements. Review and discuss agreements as appropriate with principal investigator, research team members, Clinical Research Support Office (CRSO) team members and/or supervisor, and legal staff to ensure compliance with institutional policies and procedures. Negotiate contract terms with industry representatives. Identify any problematic language that may require negotiation and/or input from other CHOP office such as Office of Technology Transfer, Risk Management, and Office of General Counsel; responsible for timely contract execution and appropriate escalation of stalled contract negotiation. Ensure consistency between the informed consent document and the clinical trial agreement. Actively participate in process improvement initiatives to provide above average customer service to the Research Institute. Collaborate with Clinical Trials Financial Management (CTFM) to ensure the business terms of agreements meet institutional requirements. Function as CRSO liaison in staff meetings with CHOP personnel and external sponsors; interpret and explain terms and conditions to internal and external personnel as required; assist colleagues with the resolution of problems related to contract terms and conditions, compliance with sponsor and institutional policy, and any other contract-related issues. Maintain active communication with all stakeholders including investigators, research personnel, CRSO management, and industry sponsors. Maintain complete and accurate database entries of all agreements negotiated. Utilize eTRACK and other institutional databases per CRSO SOPs. Generate reports as needed to measure and manage workflow efficiently and effectively. Provide reports to research teams as requested, Enhance knowledge and understanding of academic standards and policies in negotiations of research agreements through ongoing personal development. Develop, organize, participate in and/or conduct orientations, workshops, presentations, etc., on behalf of the CRSO. Assume additional responsibilities as assigned.
Qualification and Experience
The candidate should have Bachelors of Arts or Science. 1-2 years of related experience required. Must have an advanced legal degree, e.g., JD, may be sufficient in lieu of professional experience. Paralegal training and healthcare and/or clinical research experience is preferred. Equivalent mix of education and experience will be considered. Excellent computer skills including word processing, spread sheet and database skills is required. Excellent interpersonal communication skills is required. Excellent organizational skills including ability to handle confidential material is required. No prior work experience with drafting, negotiation and preparation of contracts is required; however, some formal training in legal studies is preferred. Experience with information management systems is required.
Req ID: 15687
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