Contracting Officer, Office of Clinical Research

• Independently reviews, negotiates, and drafts Confidentiality 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.
• Reviews and analyzes agreements for completeness and adherence to GW MFA and University policies and practice, conformance with associated proposals, relevant FDA regulations and clinical research compliance restrictions, risk profile, financial and academic requirements, sponsor policies, and applicable regulations, interprets and applies legal citations in contractual language.
• Provides guidance to internal stakeholders for requested revisions and amendments of legal transactions in an informed and timely fashion. Resolves contractual issues by researching applicability of FDA regulations/federal regulations or other non-federal terms and conditions relevant to clinical trials to and applying expert knowledge of Federal and GW MFA/University policies and procedures, past institutional experience and other resources to advance GW MFA’s and University’s position in finalizing contracts and clinical research transactions.
• Administers all contract management processes, including coordination with the Office of Research Integrity for review of relevant conflicts of Interest, review of subject injury language in all informed consent forms to ensure congruence 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 the Medicare Coverage Budget 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. Works closely with GW OCR Sr. Finance Analyst with issues regarding negotiation of budgets and budget amendments with sponsors, including CROs and pharmaceutical industry partners, for both federal and non-federal clinical trials sponsors.
• Work with Clinical Research Coordinators, Sr. Contracting Officer, and the Executive Director, Clinical Research Administration & Operations to resolve operational study specific contractual issues; performs follow-up on all outstanding contract issues. Works effectively with people across teams to formulate, and manage resolutions, documents approvals and business decisions.
• Support 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 within the forecasted contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon tracking system 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 of completion dates and status updates in Oncore Clinical Trial Management System (CTMS) system.
• 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. Maintains communication with Sr. Director, Business Operations and GW OCR leadership throughout the process of receipt, negotiation, and university acceptance.
• Participates in the development, implementation, and revision of processes and structures to ensure effective and compliant business processes and operations per the Director. Responsibility for securing GW Hospital legal counsel approval and Hospital CEO execution of all clinical research transactions that involve use of the GW Hospital and its facilities.
• Independently identifies contract risks by assessing scope and non-compliant contracts/agreements/nonpreferred terms. Coordinate 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 judgment in terms of internal and sponsor-required prior approvals, offers feedback on process and award management matters, and documents approvals which per University audit policies.
• Implements clinical research policies relevant to contracting and pre-award scope of activities to ensure that clinical research activities are compliant with relevant regulations; assist in creating training programs, works directly with stakeholders across the GW MFA, GW and GWUH to ensure that policies are enforced. Advises principal investigators, other faculty and researchers, departmental staff, and appropriate leadership in GW OCR regarding award terms and conditions to ensure compliance.
• Remains current with industry standard regulatory requirements for Federally funded and industry sponsored FDA regulated drug and device clinical trials, through continuing education; participation in industry groups and professional networks of research administrators.

Qualified candidates will hold a Bachelor’s degree in an appropriate area of specialization plus 5 years of relevant professional experience, or, a Master’s degree or higher in a relevant area of study plus 3 years of relevant professional experience. Degree must be conferred by the start date of the position. Degree requirements may be substituted with an equivalent combination of education, training and experience.

• MBA or JD degree desirable.
• 5 years experience in contract negotiations in a research-intensive university setting is highly desirable.
• Experience in grant and contract pre-award and post award research administration.
• Excellent understanding of clinical trial process across Phases II-IV and ICH GCP.
• Strong knowledge of the clinical research development process and legal and contracting parameters.
• Experience in working within Oncore or other Clinical Trial Management System.
• Project management experience in a fast-paced environment.
• Strong skills in problem solving, contract preparations, contract negotiation skills for grant and contract budgets.
• Quality driven outcomes through developing and/or enforcing clinical research policies, procedure, protocols, start-up processes.
• Good understanding of clinical protocols and associated study specifications.
• Strong computer skills in Microsoft Office Suite.
• Customer focused and ability to manage challenging priorities and to remain flexible and adaptable in stressful situations.
• Excellent written/verbal communication, presentation, documentation, interpersonal skills as well as strong team-orientation.
• Ability to mentor, lead and motivate staff.
• Demonstrated ability to provide quality feedback and guidance to physician researchers and peers.
• Detailed-oriented, effective organizational and administrative skills and able to handle multiple projects in a deadline driven environment.

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.