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Impacts the management, planning, development, budget, and other administrative activities of a clinical research department. Plans, manages and monitors operations to support the clinical research activities of the department. Provides excellent customer service while maximizing revenue through efficient, effective and compliant procedures. Assist with centralization of clinical trial financial management.
PATIENT AGE GROUP SERVED
Does not have direct or indirect patient care responsibilities.
DUTIES AND RESPONSIBILITIES
Clinical Research Operations:
1.Manages day-to-day business operations of the department.
2.Develops and monitors, or participates in the development and monitoring of, the annual operating budget of the department and ensures that the department operates in a cost-effective manner within budget.
3.Administers grants and contracts, both pre-award (develops/reviews study budgets, assisting in application preparation, contract set-up, CTMS set-up), A/R validation , Medicare cost analysis and post-award (revenue, expenses, monitoring accruals, prepares financial reports, etc.).
4.Manages all department cost centers including account reconciliation and variance analysis; creates ad hoc reports (P/L) and approves transactions.
5.Provide project Management for centralization of clinical trial financial management. Develop centralization SOPs, oversight and training.
6.Interfaces with TMH/TMHPO billing offices to ensure appropriate billing/coding for clinical trial budgets (proper Medicare cost analysis).
7.Supports TMHRI Leadership and Department as CTMS Manager. Prepares CTMS reports for Director and TMHRI leadership.
8.Assists Director with monitoring progress and performance of projects to include quality of services, timelines of deliverables and compliance with regulatory requirements.
9.Maintains Department financial records and files.
10.Assists Director in establishing and implementing short- and long-range departmental goals, objectives, policies and operating procedures; monitors and evaluates operational effectiveness; effects changes required for improvement.
Human Resources Coordination:
1.Assists Director with on-boarding of new employees in terms of sequencing and executing tasks/actions involving TMHRI/TMH support areas (e.g., Department Orientation, Uniforms, Telecom/IT, Equipment, supplies, training, TMHRI Credentialing/Competency, etc.).
2.Coordinates/screens all initial interviews for administrative support positions and makes hiring recommendations to the Director.
3.Manages financial support staff and coordinates workflow of financial operations team by monitoring workloads and redistributing assignments to meet deadlines and provide efficient utilization of staff. Anticipates changes in priority and arranging coverage during personnel shortages and increased demands for support.
1.Provides input in the development of operational plans for new projects and proposals as well as collaborations and outsourcing.
2.May represent the operational capabilities of the department and TMHRI in discussions with sponsors regarding potential clinical research projects; provides input regarding resource needs for potential clinical research projects.
3.Attends national meetings and investigators meetings as required.
1.Attends meetings in the Director's absence and provides information on behalf of the department.
2.Serves as back-up to Director on administrative functions in his/her absence.
3.Serves as a leadership resource for Faculty, TMHRI Leadership, and research staff on clinical research operations. Serves on related task forces and committees as required.
Bachelor's degree in business, hospital/healthcare administration or a related field required. Master's degree in business, hospital/healthcare administration or a related field preferred.
Minimum of 5 years of experience in a healthcare professional/administrative capacity required. Preferred experience in clinical research setting.
CERTIFICATES, LICENSES AND REGISTRATIONS REQUIRED
SPECIAL KNOWLEDGE, SKILLS AND ABILITIES REQUIRED
Skilled at managing multiple projects with conflicting priorities.
Extremely well-organized and detail oriented.
Excellent interpersonal skills required to deal with diverse physicians and staff.
Excellent oral and written communication skills required.
Normal indoor, controlled office environment.