ASSISTANT RESEARCH PRACTICE MANAGER

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Occupational Summary

Responsible to the Research Practice Manager (RPM) for oversight of study conduct for research studies within the assigned division(s) or cluster(s). Assists the RPM in the day-to-day management of CRU operations and people. 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. Assists in providing operational and study conduct metrics/reports to RPM.

Work Performed

Management and Institutional Responsibility

Screens, interviews, and hires clinical research professionals with faculty and RPM 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, including navigation through the Tier Advancement process.

Assists 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.

Conducts 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), oversees the operations of studies and provides regular updates to the RPM as needed. This may include study start up, enrollment, recruitment, closeout, continuing renewals, etc.

Provides research metrics to RPM in order to advise on high level decisions.

Serves 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 identifies methods and works with the RPM to improve CRU and institutional procedures and policies.

Research Operations

Supervises and provides 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.

Knowledgeable about SOM resources available to teams for assistance.

Ensures that key personnel are properly trained and document training according to institutional and regulatory policies in a timely fashion. May help navigate conversations with foreign agencies and study teams to develop or obtain the required documentation for compliance with international regulations.

May assist with communications and operational plans that include IDS/ICS.

Conducts internal quality assurance audits of specific studies and assists in preparation for external audits. Reviews and responds to audit reports, and develop and implement 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.

Prepares for and leads effective facilitation of multidisciplinary meetings in order to achieve objectives. Follows up on action items when necessary. Ensures good communication within the unit, including mentoring staff to improve communication strategies.

Safety and Ethics

Monitors compliance with institutional requirements and provides 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.

Data

Monitors compliance with institutional requirements and provides 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.

Monitors adherence to best practice and institutional goals related to return of study results. Provides consult and guidance to study teams across the CRU on planning, budgeting, and resources to share study results with participants and providers as appropriate.

Supervises and provides guidance for the studies within the CRU on reporting study metrics and progress. Collaborates with CRU biostatistical support to provide education and support to teams.

Scientific Concepts

Supervises and provides guidance for the studies within the CRU as it relates to Open Science initiative and FAIR data practices.

Assists RPM with ensuring appropriate documentation of scientific review processes, including decisions made by scientific reviewers/review committees.

Site and Study Management

Works with financial staff in developing and negotiating budgets with sponsors. Acts as the primary contact during study startup and intervenes when study teams have a conflict with sponsors and/or CROs.

Supervises and provides guidance on the use of systems and system reports to manage research participants activities and tracking/marking financial milestones and research protocol activities and maintaining current protocol information.

Collaborates with CRU Financial Practice Manager (FPM) and RPM to evaluate the feasibility of new studies. Provides input and information to assist the RPM in making decisions regarding study selection.

Reviews the finances of ongoing trials on a regular basis in collaboration with the CRU Director, RPM, PIs, Financial Manager and other clinical research professionals. Facilitates efforts to address budget related issues.

Ensures that studies within the assigned division(s) or cluster(s) are conducted in compliance with institutional requirements and policies.

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.

Monitors compliance with institutional requirements and, provides guidance to ensure that studies are closed according to best practices and guidelines.

Leadership and Professionalism

Evaluates and implements 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.

Keeps current with research updates and oversees implementation of new policies and regulations among staff members. Contributes to and represents the institution in internal and external groups related to research or therapeutic area (e.g., institutional initiatives or committees).

Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently.

Demonstrates resilience, leadership, and actively facilitates change within CRU.

Uses advanced subject matter expertise in clinical research activities to solve complex problems across assigned division(s) or cluster(s).

Develops and implements solutions within assigned division(s) or cluster (s) to improve the research process.

Creates a team environment with a culture that fosters communication.

Communicates effectively across the assigned division(s) or cluster(s) about new policies, regulatory updates, and institutional SOP changes.

This ideal candidate would have a BSN or higher, direct clinical experience in oncology or research would be an advantage and/or OCN, CCRP or ARCP.

Minimum Qualifications

Education

Work requires completion of an associate's degree. ACRP or SOCRA certification preferred.

Experience

Work requires a minimum of eight years of related experience, with at least four years in a research setting. A bachelor's degree may substitute for two years of related experience.

Duke 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 essentialjob 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.