RESEARCH PROGRAM LEADER - CENTER FOR GENOMIC MEDICINE
School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
100% grant funded
For complex scenarios, recognizes when all types of agreements are necessary. Directs teams to appropriate Duke offices for execution. Prepares FDA regulatory submissions in collaboration with ORAQ, including development, submission, and maintenance of relevant documentation. Addresses FDA review and/or potential hold issues in collaboration with the Principal Investigator (PI). Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs.
Assists with study level documentation and approvals for international studies. Is responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research participants.
Serves as the primary liaison with sponsors, IDS, and other parties as necessary. Follows protocol schema for randomization and blinding/unblinding. Prepares for and provides support for study monitoring and audit visits, including support for the reviewer.
Addresses and corrects findings. Provides oversight, training, and expertise to multiple study teams/research program regarding participant level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies) and/or require DUHS billing.
Employs strategies to maintain retention rates. Evaluates processes to identify problems with retention.
For multiple study teams, develops and oversees the implementation of strategies for meeting recruitment goals.
Provides training. Develops, oversees adherence, and trains in the use and development of SOPs across multiple study teams/research program(s).
Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies).
Provides oversight and training and lends expertise to multiple study teams. Conducts and plans for complex study visits. Leads team meetings and facilitates healthy communication between staff. Ensures good communication across multiple study teams, and mentors staff to improve communication strategies.
dentifies all AEs, and determines whether or not they are reportable. Collaborates with the PI to determine AE attributes, including relatedness to study. Conducts and documents consent for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care. Develops consent plans and documents for participants in a variety of studies.
Develops and submits documentation and information for IRB review. Communicates with the IRB staff and reviewers and handles issues appropriately. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies.
Enters and collects data. Develops data entry or collection SOPs or tools. May provide oversight or training to study team members collecting or entering data. Ensures accuracy and completeness of data for all studies, including those that are complex in nature. Recognizes data quality trends and escalates as appropriate.
May develop tools for, and train others in, data quality assurance procedures. Recognizes and reports security of physical and electronic data vulnerabilities. May develop or review RDSPs for multiple study protocols. Maps a protocol's data flow plan including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.).
Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for multiple research teams/research program, as relevant.
Independently develops substantial portions of funding proposals and grants. Assesses and determines solutions for operational shortcomings of proposals. Independently reviews articles, synthesizes the literature, and uses to assist in the development of manuscripts or grant proposals.
Using scientific proposals from the PI, develops research protocols. Uses expertise in research design to provide significant contribution to protocols or research proposals. Provides significant contribution or leadership on accepted, peer-reviewed publication or conference presentation. Mentors others in this area.
Study and Site Management:
Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CROs. Uses clinical research management system and its reports to manage research participants' activities, calendars, tracking/marking financial milestones, and all aspects of study visits. Uses required EMR functionalities to manage participants and study visits. clinical research management system and its reports to manage all protocol activities, including minimum footprint, SIP counsel, and all aspects of maintaining current protocol information.
For studies with complex supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. May forecast staffing needs. For multiple study teams, ensures that studies are conducted in compliance with institutional requirements and other policies. Oversees implementation of operational plans across multiple study teams or sites. Prepares studies for closeout and document storage.
Proactively seeks opportunities to add relevant skills and certifications to own portfolio. Provides opportunities for staff to attend key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.). Plays key role on committees and workgroups.
Demonstrates interpersonal skills to get work done efficiently. Recognizes and escalates organizational issues that could be optimized to improve research process. Demonstrates resilience and actively facilitates the research program through change. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems across multiple study teams.
Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.
Description of Portfolio Responsibilities: (Effort 100%):
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.
This position will oversee and manage several studies and will be responsible for sponsor interaction, regulatory operations, engaging w other teams like stats, budget building.
Candidate will be responsible for likely 3 or 4 studies. Community enrollment, one may be outpt treatment/prophylaxis study. 2 are device
No direct oversight of staff.
Budgets will vary in size from $75,000 to $400,000. Will interact w lab staff, stats, faculty and research scientists
Type of Research: community and oupt research activity. Budget and protocol development. Drug and device studies
Completion of a Bachelor's degree
ExperienceWork 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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