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RESEARCH PRACTICE MANAGER
Job Title: RESEARCH PRACTICE MANAGER
Job Code: 1029
FLSA: E
Job Level: 73
Revised Date: 01/08/2024
Job Family: JF 05
Occupational Summary
Responsible to the Clinical Research Unit (CRU) Director and School of Medicine (SOM) for oversight of all research activities related to study conduct within the CRU. Accountable for day to day CRU operations and people management. Ensures that clinical research professionals and investigators are appropriately trained and performing activities in accordance with good clinical practice, CRU standards, institutional policy, and regulatory requirements. Oversees and provides metrics and reports to institutional leadership on the previously mentioned activities.
Work Performed
Management and Institutional Responsibility
Oversees the operations of studies and provide regular updates to the CRU Director and School of Medicine leadership as needed. This may include study start up, enrollment, recruitment, closeout, continuing renewals, etc.
Manages staff effort distribution for the CRU to ensure that staff are appropriately assigned studies based on the volume of activity and individual staff competency.
Serves as an expert resource to all CRU study teams with regard to study conduct.
Actively encourages collaboration with SOM administration resources and offices.
Responsible for oversight or delegation of new employee identification process including screening, interviewing, and hiring clinical research professionals with faculty and department input.
Collaborates with Duke Office of Clinical Research (DOCR) and other School of Medicine (SOM) resources to conduct onboarding, training, and professional guidance for clinical research professionals.
Conducts annual performance evaluations, goal setting, and corrective action, as needed.
Serves as the Single Point of Contact for Tier Advancement, including ensuring that staff are eligible, disseminating results, educating new hires on the process, and other duties as required.
Responsible for appropriately requesting and managing clinical research system access for staff.
Establishes and assigns activities of other managers to accomplish goals of the institution and CRU.
Effectively makes decisions based on analysis of data collected via clinical research management systems.
Continuously identifies methods to improve CRU and institutional procedures and policies.
Research Operations
Oversees CRUs research activities and timelines as related to regulatory and institutional policies and processes, screening, recruitment and retention, study monitoring, audit visits, participant and study level documentation, study visits, SOPs, specimen management, IND, IDE, ITP documentation, investigational product, and contracts and agreements.
Directs teams to appropriate Duke offices and assists in resolutions if contractual issues arise.
Ensures CRU compliance with document preparation, annual reports, and amendments required by the FDA.
Ensures that key personnel are properly trained, and the training is documented, according to institutional and regulatory policies in a timely fashion.
Implements CRU wide systems for managing and documenting IP.
Conducts CRU quality assurance audits. Oversees and participate in internal and external audits of CRU studies. Reviews and responds to audit reports, and develops and implements corrective action plans in a timely manner when problems are identified.
Assists clinical research professionals in the development of participant recruitment strategies, identification of barriers to enrollment, and implementation of appropriate interventions.
Knowledgeable about SOM resources available to teams for assistance.
Collaborates to develop and ensure CRU implementation of institutional SOPs, policies, and initiatives.
Prepares for and leads effective facilitation of CRU meetings in order to achieve objectives. Follows up on action items. Ensures good communication within the unit, including mentoring managers to improve communication strategies.
Safety and Ethics
Oversees compliance with institutional requirements and serves as an expert resource at Duke pertaining to: developing and submitting documentation and information for IRB review, preparing and submitting documents needed for regulatory and safety reporting to sponsors and other agencies, identifying and documenting adverse event information, conducting and documenting consent, and developing consent documents and processes.
Data
Oversees compliance with institutional requirements and serves as an expert resource at Duke pertaining to quality data collection and capture, data flow plans, data security and provenance, and data quality assurance.
Responsible for the implementation, adoption, and monitoring of new research technologies or systems (e.g. Oncore, Maestro Care, etc.) and data capture requirements across the CRU.
Coordinates with institutional leadership on initiatives and priority setting to ensure appropriate QA processes.
Actively encourages study teams to connect with stakeholders (e.g., statisticians) and institutional resources (e.g., ISO, IRB).
Scientific Concepts
Oversees the CRU review processes to ascertain scientific integrity, impact, and inclusion in the departmental CRU research study portfolio.
Ensures appropriate documentation of scientific review processes, including decisions made by faculty scientific reviewers and review committees.
Site and Study Management
Oversees how teams communicate with sponsors and CROs.
Oversees the use of systems and system reports that manage research participants activities and financial tracking. Utilizes these systems to ensure study compliance and manage research protocol activities and maintain current protocol information.
Collaborates with CRU Financial Practice Manager (FPM) and SOM administration resources to evaluate the feasibility of new studies, including staffing and budgetary requirements, clinical and logistical considerations, and competing studies.
Works with financial staff to develop and negotiate budgets with sponsors. Knowledgeable about SOM resources available to teams for assistance.
Ensures that studies within the CRU are conducted in compliance with institutional requirements and policies and closed according to best practices and guidelines.
Serves as an expert resource to clinical research professionals and outside agencies with regard to study specific protocol requirements and problem solving related to clinical, logistical, financial and regulatory concerns.
Leadership and Professionalism
Evaluates and implements professional development and training programs offered through DOCR (e.g., Research Professionals Network (RPN), Research Wednesdays) to encourage staff retention, continuous improvement, and development.
Keeps current with research and institutional updates and oversees necessary implementation among CRU staff members. Participates or leads institutional initiatives or committees and serve in a leadership capacity in professional organizations.
May develop and implement solutions at the institutional level to improve the research process. Uses expertise and acumen to influence change at the CRU level.
Demonstrates resilience, leadership, and actively facilitate change for CRU.
Uses advanced subject matter expertise in clinical research activities to solve complex problems across the CRU.
Creates a team environment with a culture that fosters communication. Communicates effectively across the CRU regarding new policies, regulatory updates, and institutional SOP changes.
Required Qualifications at this Level
Education/Training
Work requires completion of a Bachelor's degree. ACRP or SOCRA certification preferred.
Experience
Work requires a minimum of eight years of related experience, with at least five years in a research setting. A Master's degree may substitute for two years of related experience.
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.
