Job Description Summary

Founded in 1824, the GW School of Medicine and Health Sciences ( SMHS ) is the 11th oldest medical school in the country and the first in the nation’s capital. Since its establishment, the school has been at the forefront of medical education and has grown to include highly-ranked programs in the health and biomedical sciences. With dozens of top-tier residency programs, SMHS is a competitive and esteemed destination for medical school graduates across the country.

Find out more here: http://smhs.gwu.edu/ The Office of Clinical Research ( OCR ) in the GW School of Medicine and Health Sciences is seeking an Assistant Director, Business Operations Clinical Research, SMHS . This position manages all pre-award clinical research administration services, second tier research billing charge reviews in Epic, and facilitates with post award financial team, as needed.

The Assistant

Director reports to the Chief of Clinical Research Administration and Operations, and Chief Clinical Research Officer. This position’s primary responsibility is to oversee the clinical research trial contracting and budget pre-award process and represents GWU , MFA , and Hospital with minimal supervision in highly complex negotiations of contractual and budgetary elements, and recommends execution of legal transactions by authorized officials of GWU , MFA , and Hospital. A key member of the GW OCR leadership team, this position provides direct oversight and supervision of the Sr.

Contracting

Officer, Clinical Research, and has responsibility for: initiation, review, drafting, negotiation, and finalization of a growing portfolio of GW clinical research legal transactions including Confidentiality Agreements, Non-Disclosure Agreements, Clinical Trial Agreements, federally funded grants, contracts and sub-contracts under prime Federal awards, Nonconforming Subcontracts, Master Service Agreements, Material Transfer Agreements, Data Use and Data Transfer Agreements, and other Memorandums of Understanding, as well as all Amendments or modifications to such legal transactions, providing expert guidance on matters concerning indemnification, subject injury, intellectual property, risk management, insurance, applicable rules and regulations pertaining to privacy and clinical research billing compliance, FDA regulated drug and device trials, and/or clinical research sponsored projects.

Specific Duties and Responsibilities: Independently reviews, negotiates and drafts Confidentiality Agreements, Non-Disclosure Agreements, Clinical Trial Agreements, federally funded grants, contracts and sub-contracts, Nonconforming Subcontracts, teaming agreements, Master Service Agreements and Master Clinical Trial Agreements, Material Transfer Agreements, Data Use and Data Transfer Agreements, and other Memorandums of Understanding, all subsequent amendments or modifications to a contractual document, and other contractual agreements with industry/commercial, federal and international entities on behalf of the GW MFA and University. Administers all contract management processes, including coordination with the Office of Research Integrity for review of relevant conflicts of interest, subject injury language in all informed consent forms to ensure alignment with the final language in the clinical trial agreements, reviews by risk management, Hospital, and University general counsel, and all communications with sponsors, CROs and funding partners. Reviews contracts for completeness and accuracy and ensures that corrections are appropriately made and documented.

Works closely with Sr.

Financial

Analyst in ensuring that all terms in the negotiated budgets for CTAs and any subsequent Amendments to the CTAs are properly reflected in the final CTA . Negotiates budgets and budget amendments with sponsors, including CROs and pharmaceutical industry partners for both federal and non-federal clinical trials sponsors. Supports in generating amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract proposal or internal processes; and initiates and introduces creative ideas and solutions.

Works with forecasted contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon tracking systems in real time. Collaborates with internal and external legal, finance, compliance, risk/insurance, and clinical operations to include communicating and explaining legal and budgetary issues. Maintains contract templates and site-specific files and databases, and has responsibility for updating the GW OCR contracting manual and relevant SOPs, performs quality control and arranges execution of clinical trial agreements (CTAs) as well as archival of documents into repositories and capture the completion dates and status updates in OnCore Clinical Trials