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DIR, CLINICAL RES EDUC TRAINING AND OPS
Job Title: DIR, CLINICAL RES EDUC TRAINING AND OPS
Job Code: 1176
FLSA: E
Job Level: 17
Revised Date: 05/01/2021
Job Family: JF 28
Occupational Summary
Assist the Associate Dean for Clinical Research with identification, strategic planning and development of emerging curricula designed to meet the growing demand for skilled research and/or grants management professionals at Duke University. Lead or participate in Duke University training development teams (including interdisciplinary curriculum teams) leading to the design, implementation and maintenance of a high quality training and professional development initiative through educational materials and activities. In addition, provide central oversight for team leads on study start up activities, and work surrounding study operations and implementation. Make recommendations regarding data integrity/security, data management, internal and external regulatory work and clinical research support of validation and verification team specific to billing grids, daily reports and data validation. Provide direction and navigation support for clinical research operations. Provide oversight and direction for work for the Duke Office of Clinical Research (DOCR) and coordination of daily operations, education and training related to research operations. Provide input into DOCR budget.
Work Performed
Assist in determining and developing long and short term goals, strategic planning, and program development for education and outreach programs within the research and/or grants management community.
Direct the communications content related to clinical research operations, including overview of policies and practices for the research community through newsletter, CRU newsletter, and DOCR website.
Represent, educate, and train research staff on initiatives of the Duke Office of Clinic Research (DOCR), including regulatory compliance, data provenance, data integrity, roles and responsibilities, GCP, and other research domains.
Develop and maintain liaison with clinical trials participants including, but not limited to, researchers clinicians, university administration, Food and Drug Administration, CMS regulations, industry sponsors of research and others, including Medicaid and other billing compliance.
Manage activities and facilitate communications; prioritize new projects and maintain current sponsor relationships to include clinical trials.
Supervise Manager, Maestro Care and Associate Director of Research Operations to identify and implement processes to streamline study feasibility and start up process with centralization of clinical research billing oversight in DOCR.
Direct Maestro Care study team meetings and protocol evaluations as appropriate to support needs of the clinical trial project teams.
Create skilled Maestro care build team for billing calendars and order sets.
Work with Associate Dean and Compliance offices to create policies for managing clinical research activity and Maestro Care implementation for research at Duke.
Provide oversight for research feasibility team daily report deliveries and data validation.
Communicate changes in policy and procedures with CRUs.
Engage CRU RPMs and FPMs to participate early in the development process to aid in buy in and uptake of central review of protocol implementation.
Advise and participate in the review and selection of a Clinical Trial Management System.
Serve as senior lead trainer, providing advanced level educational training and professional development experiences to Duke University faculty and staff.
Teach certain advanced level classes, develops and coordinates Manager training and assists the Director in the development and maintenance of on-line training modules.
Serve as expert resource to the community in area of training and identifying training needs within the research community where further training is required. Supervises the Training Coordinator(s) to ensure classes are scheduled and delivered in a timely manner.
Ensure that appropriate registration and tracking processes are employed.
Work with Training Coordinator(s) in the development of certain online training initiatives.
Supervise the Education Coordinator in the delivery of entry level and certain advanced level classes.
Work with Maestro Care team to ensure the Duke research user community is identified and trained.
Communicate updates to the research community about Maestro Care wave rollouts.
Serve as project manager for multiple curriculum development efforts by coordinating team meetings, maintaining meeting records, verification of decisions and consensus among team members.
Supports the efforts of the Assistant Dean in developing a comprehensive, multifaceted training approach for Duke University faculty and staff.
Work closely with Clinical Research Unit research and financial practice managers to determine CRU education and training needs and develop resident/fellow training programs.
Interface with CRU directors on education and training plans to seek guidance for buy in for program to meet Compliance requirements.
Act as DOCR liaison to CRU RPM and FPMs.
May designate work to staff involved in training including scheduling of work assignments and deadlines; provide input to Assistant Dean for hiring, performance, planning and evaluation.
Direct DOCR personnel functions, including, but not limited to, time and attendance monitoring, direct hiring, performance appraisals for team leads, promotions, space management and staff development assessments.
Resolve problem situations related to staffing, onboarding, and management of current and future employees.
Develop, conduct and administer DOCR in house and external training initiatives including oversight of development of SOPs for operations, education and training as it relates to Duke Clinical Research processes.
Collaborate with IT applications team to communicate business and research needs and plan for resources around infrastructure requirements, specifically as pertains to billing, data validation, and research support metrics reporting.
Prepare operating reports and analyses reflecting progress, metrics, and appropriate recommendations and conclusions.
Collaborate in preparation of research support budget based on research operations plans for growth.
Serve on internal Research Data Security Plan (RDSP) working group to develop process for ongoing RDSP update.
Work with IRB and CRUs for ongoing RDSP development and implementation, as well as lead training efforts for RPMs and IT professionals.
Provide outreach education to CRUs about DOCR support available through REDCap.
Prepare reports and analyses reflecting progress, adverse trends and appropriate recommendations or conclusions.
Perform other related duties incidental to the work described herein.
The above statements describe the general nature and level of work being performed by individuals assigned to this classification.
This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Required Qualifications at this Level
Education/Training
Bachelor's degree in a scientific, allied health or related field of study is required.
Experience
Minimum of ten years of experience with management of research staff, experience with grant proposals and budget development. At least one year of experience in proven leadership and effective management of the work of a large staff.
General knowledge of internal and external research compliance regulations.
Skills
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
