Assistant Director, Business Operations Clinical Research, SMHS

• 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 Management System (CTMS).
• Acts as a communication liaison between GW OCR, clinical study staff, and internal and external customers during the clinical trial start up process. Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues. Prepares correspondence as necessary.
• Independently identifies contract risks by assessing scope and noncompliant contracts/agreements/nonpreferred terms. Coordinates action plans for mitigation of higher risk agreements. Identifies contractual or process issues in projects (i.e. compliance, conflict of interest, export control). Independently exercises excellent judgement in terms of internal and sponsor required prior approvals, offers feedback on process and award management matters and documents approvals per University audit policies.
• Identifies contractual or process issues including analysis of legal transactions, detailed budgets and adherence to all applicable policies and regulations.
• Responsible for securing and overseeing approvals of all clinical research transactions that involve use of the GW Hospital and its facilities.
• Resolves contractual issues and applies expert knowledge of Federal and GW MFA/University policies and procedures.
• Provides direct oversight of:
  • Sr. Financial Analyst or budget preparation, performance of Medicare Coverage Analysis (MCA), and negotiation for all industry supported clinical trials and clinical research.
  • Dedicated Research Program Manager of grant and contract proposals through MyResearch for all 14 clinical departments.
  • Sr. Contracting Officer.

• Support the SMHS Assistant Dean for Finance in the strategic planning and development for clinical research revenue cycle and billing compliance.
• Accountable for development of metrics to evaluate the performance of the business Operations Unit, and the ongoing development and monitoring of control systems to track research billing reviews in Epic.
• Creates and delivers training and orientation to introduce the GW OCR Business Operations to faculty and research program managers and coordinators.
• Participates as a member of the Epic Research Advisory Committee (RAC) and advises on matters relevant to the operations of the GW OCR Business Operations Unit.

• Preferred Master’s Degree in business, accounting, finance, public administration, healthcare administration, nursing or related field
• Experience and demonstrated expertise in both federal and non-federal clinical research grant and contract administrative management, including preparation and submission of grant proposal and contract policies
• Experience in managing in a complex academic medical center or physician practice group environment
• Excellent understanding of clinical trial start-up processes across Phases II-IV and ICH GCP
• Good understanding of clinical research trial protocols, associated study specifications, and research development and legal parameters
• Comprehensive knowledge of legal and budgetary elements in clinical research contracting with pharmaceutical companies and medical device manufacturers for FDA
• Direct experience in review of consent forms for FDA regulated clinical research
• Demonstrated excellence in negotiation skills and techniques
• Demonstrated experience and knowledge of FDA, OIG, and CMS requirements pertaining to clinical research and research billing
• Experience with OnCore and Epic is highly desired
• Proficient in Microsoft Word, Excel, PowerPoint, Outlook, and Oracle

The university is an Equal Employment Opportunity/Affirmative Action employer that does not unlawfully discriminate in any of its programs or activities on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity or expression, or on any other basis prohibited by applicable law.