Clinical Research Business Manager

Hiring a Clinical Research Business Manager to support the pre-award and financial operations for clinical research including the clinical research unit, a centralized clinical research support office and pre-award operations.

Reporting to the Executive Director, Clinical Research, the Clinical Research Business Manager (CRBM) provides advanced research administration, financial management and subject matter expertise to research centers, departments, institutes, and programs in Clinical Research Operations. The individual supports all faculty and staff conducting clinical research in partnership with the Research Business Office and Clinical Research Support Unit. The CRBM is responsible for supporting clinical research ensuring that strategic objectives/deadlines are achieved. The CRBM is tasked with reviewing and monitoring all clinical research proposals regardless of funding source, reviewing and approving expenditures as assigned, delegating work flow, managing research administrative and financial activity with support staff and multiple Principal Investigators (PIs), monitoring financial management of funding, interacting with other centralized offices such as Research Regulatory Affairs, Foundation, Research Institutes, Tech Transfer, Human Resources, Accounts Payable, Research Accounting, Sponsored Projects, scientific core facilities, and other ancillary departments. The CRBM will be responsible for the financial management of the Clinical Research Unit and other centralized resources within the Clinical Research Support Office. The CRBM will provide subject matter expertise to guide and assist the Executive Director, Clinical Research and CRI leadership with short and long-term administrative decisions. The position will lead and serve on steering committees and/or project teams in conjunction with or on behalf of the Executive Director for initiatives that benefit clinical research, the clinical research unit, CRI and institution. The CRBM will meet regularly with Research Center Directors and PIs to resolve budgetary and/or financial and/or operational issues related to their clinical research portfolio. The individual will lead the development of SOPs and will develop educational training programs as assigned.

Minimum Education
Bachelor's Degree Finance, Business Administration, Hospital Administration, or related field (Required)

Minimum Work Experience
8 years Progressive clinical research administrative experience in an academic or academic medical center environment including extramural fund management and clinical research financial operations management. (Required)
3 years Supervisory experience (Preferred)

Required Skills/Knowledge
- Demonstrated knowledge of Federal regulations related to Clinical and Sponsored Research Administration, including but not limited to the Uniform Guidance, Cost Accounting Standards, Federal Acquisition Regulations, and major Federal funding agency guidelines.
- Ability to recruit, train and lead a diverse staff to new and changing Clinical Research and Sponsored Programs initiatives and to create an environment within the office which promotes staff involvement, productivity, and continuing education.
- Strong interpersonal skills with a high degree of analytical ability, ability to identify problems and find creative & effective solutions, and strong verbal and written communication skills.
- Ability to maintain confidentiality.
- Strong understanding of Project Management concepts and ability to maintain and manage deadlines and multiple projects.
- Knowledge of business and management principles.
- Ability to direct, manage, implement, and evaluate operations.
- Ability to establish goals, and objectives that support the strategic plan.
- Ability to effectively plan, delegate and/or supervise the work of others.
- Ability to lead, motivate, develop, and train others.
- Ability to represent Clinical Research Support Unit concerns in interactions with other departments within the organization.
- Advanced proficiency with personal computer and related software particularly excel

Required Licenses and Certifications
Certified Research Administrator (CRA) (Preferred)

Functional Accountabilities
Responsible Conduct of Research

• Ensure compliance with standards for the responsible conduct of research.

• Plan, conduct, and manage research projects within the federal, state, local and institutional regulations, policies and procedures, guidelines and standards

• Responsible for appropriate administration of clinical research funds and resources.

• Ensure compliance with all annual training requirements.

• Reviews and approves appropriate access requests for personnel in CNRI.

• Encourage and share new ways of making the right work easier to do.

• Recognize and share incremental improvements in operations.

• Promote the success of organizational and department initiatives by clearly aligning programs to the mission.

Budget and Financial Management

• Under directions of the Executive Director, and VP, implement long-range financial plans, analysis, and recommend adjustments where appropriate.

• Responsible for financial projections/budgets, monitoring capacity to support effective operating and capital budget planning for center, department, and/or institute.

• Responsible for ensuring financial data is accurate and provided to faculty on a regular basis. Helps to optimize financial processes.

• Monitor and prepare periodic performance data for budget variances and collaborates with management team to resolve discrepancies; action plan to meet budget gaps.

• Monitor payroll distribution of clinical research staff to ensure salary expenses are within budgeted projections; ensures timely correction of payroll allocation.

• Conduct financial research and analysis of financial data to identify erroneous transactions and communicate with leadership to address gaps and process corrective actions.

• Review and approve all invoices for assigned areas and reconcile revenue received

• Review and approve financial reports and analyses for all budgets and expenses for general reporting to Center Directors and PIs.

• Approve Labor and Non-Labor Cost Transfers.

• Participate in project financial close out processes (e.g., clear encumbrances, close POs, closeout sub-awards, pay invoices, etc.) as appropriate.

• Manage extramural funds (e.g., SPF's, federal and non-federal funds, contracts, clinical trials, grants, gifts, endowments and other forms of financial support and internal funds endowments, and institutional operational budgets through periodic reporting of financial position of each PI, regular and ad hoc reports for faculty trends including expenditure, grant income, resource allocation, and comprehensive forecasting of average spending. Report regular updates to Center Directors, Executive Director, and VP.

• Review and approve purchase requisitions, Vouchers, reimbursements, travel authorizations and business expense reports

• Ensures that budgets are drafted and finalized within appropriate timelines and follows all grant and clinical research regulations, including but not limited to salary caps, correct calculation of indirect costs, ensure completion of coverage analysis, correct calculation of patient care, clinical trial effort transfers, etc.

Research Administration

• Manage, supervise, and mentor a clinical research pre-award team providing business and financial management support services to center, department or institute.

• Coordinate and assist in development and submission of typical proposals and as needed on large and complex proposals.

• Monitor CRU spending on grants so that all expenditures are appropriate and allowable within the grant budget and period, and ensure work adheres to relevant policies and regulations.

• Respond to inquiries for interpretation, monitoring, and analysis regarding operating policies and procedures.

• Ensure accuracy of personnel time and effort reporting in ECRU system and work with GFA's and PI to update/correct errors.

• Deliver training to research community, faculty and departmental administrative staff on a regular basis regarding clinical research administration and compliance

• Meet regularly with Executive Director and VP to discuss Clinical Research matters and operational issues and develop plans to further the goals of the Organization.

• Effectively collaborate on a continual basis with colleagues in CRI, Finance, Legal and other collaborators, to implement efficient and relevant business processes

Clinical Research Unit Support

• Provide support for CRU business activities, including but not limited to: purchasing, facilities, travel, and reporting required by the institution.

• Maintains working relationship with central administrative and clinical departments through daily interactions.

• Mentors assigned staff.

• Serves on committees as requested.

• Works with Center Directors to ensure support for clinical research administration is meeting needs.

Clinical Research Administration

• Ensures that coverage analysis is complete all studies that have a patient care component, regardless of sponsor.

• Ensures that study budgets are accurate and complete including administrative charges and pass throughs included

• Ensures that clinical staff are compensated accordingly whether through traditional allocations on cost reimbursable awards or via Clinical Trial Effort transfers on fixed and per patient awards.

• Works with faculty and staff to determine correct payments and ensure that they are received and posted properly.

• Ensure that clinical research budgets are completed timely and accurately and review them within final industry contracts to ensure that they are correct.

Project Management

• Creates project plans with milestones, deliverables and accountability assignments.

• Proactively work with project team to ensure projects are delivered on budget in a timely manner.

• Participate in short- and long-range planning and policy or program development by analyzing operational policies, resource utilization, etc. and developing recommendations for Center management.

• Maintain professional growth and development and enhance quality improvement initiatives and regulatory compliance through seminars, workshops, and professional affiliations to keep abreast of the latest trends in field of expertise.

• Perform other related duties as assigned or requested.

• Design and develop business plans and financial projections to assist in the development, evaluation and implementation of new ventures, services, partnerships and acquisitions.

• Monitor the return on investment (ROI) semi-annually for each business plan and submit to leadership team with analysis and recommendations.

• Work with leadership team to develop performance metrics and evaluation tools for measuring each aspect of clinical contracts and quarterly performance indicator reports.

• Provide analysis of performance metrics reports and updates financial dashboard.

Management and Leadership

• Responsible for training, development and performance management of assigned staff

• Act as a liaison between staff and faculty when necessary.

• Ensures that faculty and research staff at all levels are meeting all research laws, regulations, policies and guidance and that administrative deliverables are accomplished in a timely and accurate way.

• Identifies and implements processes to improve daily operations.

• Develops policies guided by code of federal regulations

• Creates internal guidelines to enhance compliance with Children's National and sponsor regulations and continually updates as needed to remain current.