The Research Business Manager plans, develops and supports the budgetary and financial components of opening and maintaining clinical research projects within the CCBD clinical research office. This includes evaluating proposed research projects, reviewing clinical research protocols, helping to create budgets and collaborating with physician investigators and research coordinators in the financial management of their studies. The Research Business Manager will be responsible for ensuring billing compliance and timely invoicing for patients enrolled on research studies. Collaborating with the Pediatric Hematology/Oncology grants/contracts management team at UT Southwestern will ensure smooth collaboration and communication between principal investigators, outside collaborating institutions, sponsors, study staff, hospital administration and study participants.
The following describes the basic position duties that an employee MUST be able to perform for this role. This information is intended to be descriptive of the key responsibilities of the position. The list of essential functions below DOES NOT identify all duties performed by any single person in the position.
Requires in-depth professional knowledge and practical/applied expertise in own discipline and basic knowledge of related disciplines within the broader professional field
Has knowledge of best practices and how own area integrates with others; demonstrates awareness of the industry, including regulatory, evolving customer demands, and the factors that differentiate the organization in the market
Acts as a resource for colleagues with less experience; may lead projects with manageable risks and resource requirements
Solves complex problems and takes a new perspective on existing solutions; exercises judgment based on the analysis of multiple sources of information
Impacts a range of customer, operational, project or service activities within own team and other related teams; works within broad guidelines and policies
Works independently, receives minimal guidance
Explains difficult or sensitive information; works to build consensus
JOB SPECIFIC RESPONSIBILITIES:
Review research protocols with research coordinator and/or research faculty and prepare a comprehensive budget and pricing form which encompasses CMC costs of the clinical trial or other research project, including clinical and personnel costs. Collaborate with UT Southwestern's Division of Pediatric Hematology and Oncology, Children's Research Department and other departments as necessary to develop research pricing quotes and to facilitate execution of service orders between UT Southwestern and Children's, and to ensure that Children's is adequately reimbursed for all direct costs. Responsible for working with Children's and UT Southwestern to assure all research related service orders reflect the approved pricing and are fully executed and invoiced appropriately and timely (with regard to both service date and sponsor payment date). Collaborate with the Institutional Review Board, Research Department, Principal Investigators, and other study staff to maintain documentation mandated by the IRB, FDA, OHRP, UT Southwestern and Children's.
Work internally with ancillary departments to implement process improvements that reduce risk of errors and/or unauthorized research activities being performed; along with research manager. Identify training needs of research staff and implement formal and informal programs. Provide 1:1 consultation to research coordinators and research faculty on proper financial procedures required to initiate research at Children's.
Work cooperatively with UT Southwestern's Division of Pediatric Hematology and Oncology in the administration of budgets, contracts and research accounts for new and existing studies in collaboration with Children's Research Department. Ensure compliance on individual research projects, including review and correction of patient charges on a regular basis, reconciliation with Clinical Trial Mgmt Systems (REVEAL Study Manager and Velos), and required follow-up. Ensure department expenses billable to specific studies, such as supplies, equipment and participant stipends, are properly recovered from cooperative group, consortium, industry sponsored and/ or grant funds. Provide support and consultation on financial issues to clinical research coordinators, faculty and other researchers, as well as all staff engaged in research.
Minimum 3-5 years of related experience. Financial oversight, clinical trial coordination, research/healthcare related budgeting/contracting/negotiating/proposal development Required
Minimum 5-7 years of related experience preferred
Four-year Bachelor's degree or equivalent experience Required
Bachelor's degree in Business Administration, Healthcare Administration, Basic Sciences or related field required. Master's degree Preferred
Graduate or professional work or advanced degree; or equivalent experience Preferred
Specific Knowledge, Skills and Abilities:
Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjust effectively to work within new work structures, processes, requirements, or cultures.
Use appropriate interpersonal styles to establish effective relationships with customers and internal partners; interact with others in a way that promotes openness and trust and gives them confidence in one's intentions.
Meet patient and patient family needs; take responsibility for a patient's safety, satisfaction, and clinical outcomes; use appropriate interpersonal techniques to resolve difficult patient situations and regain patient confidence.
Ensure that the customer perspective is a driving force behind business decisions and activities; craft and implement service practices that meet customers' and own organization's needs.
Develop and use collaborative relationships to facilitate the accomplishment of work goals.
Identify and understand issues, problems, and opportunities; compare data from different sources to draw conclusions; use effective approaches for choosing a course of action or developing appropriate solutions; take action that is consistent with available facts, constraints, and probable consequences.
Take prompt action to accomplish objectives; take action to achieve goals beyond what is required; be proactive.
Deal effectively with others in an antagonistic situation; use appropriate interpersonal styles and methods to reduce tension or conflict between two or more people.
Effectively manage one's time and resources to ensure that work is completed efficiently.
Accomplish tasks by considering all areas involved, no matter how small; showing concern for all aspects of the job; accurately checking processes and tasks; being watchful over a period of time.
Set high standards of performance for self and others; assume responsibility and accountability for successfully completing assignments or tasks; self impose standards of excellence rather than having standards imposed.
Assimilate and apply new job-related information in a timely manner.
Clearly convey information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand and retain the message.
is such a privilege. It is one of the top pediatric hospitals in the country. The opportunities available to you for education and career advancement are virtually limitless. Once people in the community find out where you work, they are eager to share their Children’s Health experiences and the impact it had on their lives.
Amy, RN, BSN, AE-C
Clinical Research Coordinator