Research Program Leader - Obstetrics and Gynecology (Urogynecology)

Research Program Leader - Obstetrics and Gynecology (Urogynecology)

Work Arrangement : Requisition Number : 246418 Regular or Temporary : Regular Location :

Durham, NC, US, 27710

Personnel Area : MEDICAL CENTER Date : Jul 5, 2024

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.

Duke University’s Department of Obstetrics and Gynecology has an immediate opening for a Research Program Leader in our Urogynecology Division.

We are seeking individuals with a scientific background and excellent communication skills to lead our Urogenital Microbiome research program.

Our team conducts innovative laboratory and translational (i.e. using human specimens) research to better understand how the urinary microbiome is involved in common female conditions like recurrent urinary tract infections and overactive bladder.

While not required, ideal candidates will have an advanced degree (Master’s or PhD), and knowledge of laboratory-based sciences.

In addition, excellent verbal and written communication skills are essential. The individual in this position will work under the direction of PI, Dr.

Nazema Siddiqui and will regularly interact with laboratory personnel, colleagues and collaborators from other institutions, and trainees involved in the research program.

Duties will include but are not limited to : program and website development in collaboration with PI, project management, grant-writing, manuscript-editing, assistance with regulatory activities related to research program, participation in financial reconciliation and budget meetings, as well as coordination and supervision of other members of research program (e.

g., laboratory technician, post-doctoral researcher, students, other trainees). In addition, there will be opportunities to attend relevant scientific meetings, facilitate social media engagement, and assist with community engagement and fundraising efforts for the research program.

While this position does not involve clinical research in patients, human subjects research training will be required due to the need to manage data from human research subjects and associated biospecimens.

Total budgets for existing projects are approx. $2 million. The program has several additional proposals underway with the potential for more funding.

Work Performed

Operations :

For complex scenarios, recognizes when agreements are necessary within the research program.

Facilitates the process by coordinating with study teams and appropriate Duke offices. Knowledgeable in regulatory and institutional policies and processes;

applies appropriately in study documentation, protocol submissions, and SOPs.

May train others in these policies and processes.

Prepares for and provides support for study monitoring and audit visits, including support for the reviewer.

Addresses and corrects findings. Develops or helps develop SOPs.

Leads effective facilitation of team meetings in order to achieve objectives. Ensures good communication across multiple study teams, and mentors staff to improve communication strategies.

Ethics : Develops and submits documentation and information for IRB review.

Communicates with the IRB staff and reviewers and handles issues appropriately.

May train or oversee others.

Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies.

Data : Selects data capture methods and discusses advantages and disadvantages of each. Implements data capture methods at the unit, division, or departmental level.

Independently designs ECRFs and EDCs to collect data according to protocol. Recognizes and reports security of physical and electronic data vulnerabilities.

May develop or review data lifecycle and management plans for multiple study protocols.

Documents and maintains documentation to facilitate data sharing during publication or study closeout.

Serves as an expert resource to multiple study teams / research program with regard to mapping data flow.

Predicts areas of vulnerability in the data flow plan.

Determines areas where data provenance may be compromised, and helps study teams / research program staff work through solutions.

Ensures that study teams are familiar with data flow resources at Duke.

Innovatively uses technology to enhance a research process.

Develops reports on study progress for the PI and other study team members and collaborators.

Creates clear visualizations to help communicate key information to stakeholders.

Science : Assists with or contributes to the development of funding proposals.

Independently conducts literature searches and reviews.

Demonstrates and applies a basic understanding of open science practices and the FAIR data principals.

Using scientific proposals from the PI, develops elements of research protocols. Demonstrates a basic understanding of the elements of research study designs.

Contributes to the development of scientific publications or presentations.

Serves as an author on poster presentations or publications.

Study and Site Management :

Collects appropriate information to determine whether the study team's participation in a specific trial is feasible.

May make recommendations. Oversees management of resources (staff, supplies, equipment) for multiple study teams / research program.

May manage the budget for research studies.

Ensure that studies are conducted in compliance with institutional requirements and other policies.

Follow, and may develop or implement, operational plans (e.g. protocol-specific systems and documents including process flows).

May train or oversee others. Prepares studies for closeout and document storage.

Leadership : Works with the manager to understand areas of opportunity and develop a training plan. Takes training courses and applies the knowledge and skills.

May also train others in the skills learned. Keeps current with research updates by attending key external offerings (i.e.

Research Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job.

May disseminate information to others. Serves on committees and workgroups internal to Duke or externally in therapeutic area of research.

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

Develops and implements solutions that work within the existing leadership or organizational structure.

Actively facilitates and leads multiple study team's adoption of change in their working environment.

Uses advanced subject matter expertise in the therapeutic area or clinical research to solve complex problems or foster innovation within the research program.

Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

Establishes and assigns the activities of the research program team members to accomplish the study goals.

Description of Portfolio Responsibilities : (Effort 100%) :

Urogenital microbiome research program (under PI, Nazema Siddiqui). Responsibilities include assisting PI with administrative tasks and management of several federally and non-federally funded projects, including writing grants, manuscript editing, website and social media programming.

Assisting with coordination and management of trainees (undergraduate & graduate students, GME trainees doing research, research scholars) within program.

Currently 3 studies, with the potential for more.

Predicting Phenotypes in Overactive Bladder : R01-funded program studying an existing dataset and samples previously collected in 2 large cohort studies.

Requires data management skills, project coordination skills

• Development of Humanized Mouse Models for Studies of the Urogenital Microbiome
• Human Microbiome Study in ESTEEM - reanalysis of samples from prior clinical trial
• Two further studies in development regarding UTI diagnostics and probiotics for UTI prevention

Determines short- and long-term goals of the research program / shared resource in collaboration with investigator(s).

Identifies research programs / shared resources gaps, constraints, needs, and milestones; helps develop operational sustainability plan and communicates with PI to plan necessary resourcing.

Manages and documents all aspects of research project lifecycle including : initiation, planning, executing, monitoring, and closing.

Directs project staff in the execution of project activities in accordance with project plan and timeline.

Communicates project / program progress with all major stakeholders and adjust plans and timelines according to feedback.

Manages the research program or shared resource operations.

Monitors and adheres to the established budget, and assists with budget development. Ensures that institutional communications are shared with research program staff and faculty.

Maintains communication within program and with other departments or offices to accomplish the program objectives.

Manages, mentors, and / or trains staff. Maintains an awareness of regulations, policies, and resources relevant to research and therapeutic area and applies knowledge to the development and execution of operational plan.

Ensures that all programs and projects are compliant with all relevant regulations and policies. Provides guidance to staff on best practices in research study or program conduct (e.

g., recruitment, consenting, study documentation, program evaluation, data capture, etc.).

Provides intellectual contribution to the research program or shared resource, including developing and editing research proposals and manuscripts.

Represents research program or shared resource on behalf of the PI at internal and external meetings.

Minimum Qualifications

Education

Completion of a Bachelor's degree

Experience

Work requires a minimum of four years of research experience (e.g., experience. research, clinical, interaction with study population, program coordination).

A Master's degree may substitute for two years of related

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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.

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