Assistant Director, Business Operations Clinical Research, SMHS

Employer
George Washington University
Location
Washington, Washington DC
Salary
Negotiable
Posted
Apr 19, 2024
Closes
Apr 29, 2024
Ref
2746048322
Position Type
Assistant / Associate
Hours
Full Time
Work Mode
On-site
Employment Type
Contract
Organization Type
Academic
I. DEPARTMENT INFORMATION

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:

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 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.
Performs other related duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.

Minimum Qualifications:

Qualified candidates will hold a BA/BS in a related discipline plus 6 years of relevant professional experience or, a BA/BS in a related discipline plus 5 years of relevant professional experience with a certification or, a Master's degree or higher in a relevant area of study plus 4 years of relevant professional experience. Degree must be conferred by the start date of the position.

Additional Required Licenses/Certifications/Posting Specific Minimum Qualifications:

Preferred Qualifications:
  • 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
Typical Hiring Range

Commensurate with Experience.

II. POSITION INFORMATION

Campus Location:

Foggy Bottom, Washington, D.C. College/School/Department:

School of Medicine and Health Sciences (SMHS) Family

Research and Labs Sub-Family

Clinical Research Operations Stream

Management . click apply for full job details