Duke University Job Description:
Job Title: ASSIST RESEARCH PRACTICE MANAGER
Job Code: 1045
Job Level: 78
Revised Date: 08/01/2021
Job Family: JF 05
Responsible to the Research Practice Manager (RPM) for oversight of study conduct for research studies within the assigned division(s) or cluster(s). Assist the RPM in the day to day management of CRU operations and people. Ensure 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. Assist in providing operational and study conduct metrics/reports to RPM.
Management and Institutional
Responsibility Screen, interview, and hire clinical research professionals with faculty and RPM input.
Collaborate 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, including navigation through the Tier Advancement process.
Assist with staff effort distribution, for the assigned divisions or clusters, to ensure that staff are appropriately assigned studies based on volume and individual staff competency.
Conduct annual performance evaluations and performance improvement plans with staff; consulting with Human Resource Manager and RPM if needed.
For assigned division(s) or cluster(s), oversee the operations of studies and provide regular updates to the RPM as needed. This may include study start up, enrollment, recruitment, closeout, continuing renewals, etc.
Provide research metrics to RPM in order to advise on high level decisions.
Serve as an expert resource to assigned division (s) or cluster(s) with regard to study conduct and is knowledgeable about other resources at Duke.
Continuously identify methods and work with the RPM to improve CRU and institutional procedures and policies.
Supervise and provide guidance on research operations for the studies within the assigned division(s) or cluster(s). This includes: 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.
Ensure that key personnel are properly trained and document training according to institutional and regulatory policies in a timely fashion.
Assist clinical research professionals in the development of participant recruitment strategies, identification of barriers to enrollment, and implementation of appropriate interventions.
Should be knowledgeable about SOM resources available to teams for assistance.
Conduct internal quality assurance audits of specific studies and assists in preparation for external audits.
Review and respond to audit reports, and develop and implement corrective action plans in a timely manner when problems are identified.
Lead multidisciplinary team meetings by establishing attendance lists, agendas, creating action items, and following up on action items.
Safety and Ethics
Monitor compliance with institutional requirements and provide guidance to assigned division(s) or cluster(s), 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.
Monitor compliance with institutional requirements and provide guidance to assigned division(s) or cluster(s) at Duke pertaining to quality data collection and capture, data flow plans, data security and provenance, and data quality assurance.
Guides assigned division(s) or cluster(s) to institutional resources as necessary for study compliance with data processes and policies (e.g., ISO, IRB).
Performs data audits on specific studies and provides corrective action as needed.
Assists with and provides guidance on the implementation of new technologies and data capture requirements across the CRU.
Assist RPM with ensuring appropriate documentation of scientific review processes, including decisions made by scientific reviewers/review committees.
Site and Study Management
Collaborate with CRU Financial Practice Manager (FPM) and RPM to evaluate the feasibility of new studies.
Provide input and information to assist the RPM in making decisions regarding study selection.
Work with financial staff in developing and negotiating budgets with sponsors.
Should be knowledgeable about SOM resources available to teams for assistance.
Review the finances of ongoing trials on a regular basis in collaboration with the CRU Director, RPM, PIs, Financial Manager and other clinical research professionals.
Facilitate efforts to address budget related issues.
Serve 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.
Ensure that studies within the assigned division(s) or cluster(s) are conducted in compliance with institutional requirements and policies.
Acts as the primary contact during study startup and intervenes when study teams have a conflict with sponsors and/or CROs.
Leadership and Professionalism
Keep current with research updates and oversee implementation of new policies and regulations among staff members.
Evaluate and implement professional development and/or training programs offered through DOCR (e.g., Research Professionals Network (RPN), Research Wednesdays) to encourage staff retention, continuous improvement, and development.
Contribute to and represent the institution in internal and external groups related to research or therapeutic area (e.g., institutional initiatives or committees).
Uses advanced subject matter expertise in clinical research activities to solve complex problems across assigned division(s) or cluster(s).
Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently.
Create a team environment with a culture that fosters communication.
Communicate effectively across the assigned division(s) or cluster(s) about new policies, regulatory updates, and institutional SOP changes.
Develop and implement solutions within assigned division(s) or cluster (s) to improve the research process.
Demonstrate resilience, leadership, and actively facilitate change within CRU.
Work requires completion of a Bachelor's degree. ACRP or SOCRA certification preferred.
Work requires a minimum of six years of related experience, with at least four years in a research setting. A Master's degree may substitute for two years of related experience.
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.
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.