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.

Operations:
Works with institutional leaders and offices to handle complex issues relatedto contracts and agreements. Hel ps the research program resolve complicatedcontractual problems. Serves as an IND submissions expert resource. Assists junior staff to address FD A review or issues. Provides oversight and guidance to those preparing documents, annual reports, and amendments required by the FDA . Serves as an expert resource to multiple study teams/research program regarding regulatory and institutional policiesand processes. Maintains study level documentation for international studies.May develop resources and tools for management of international studies, and/orcoordinate wit h other entities or offices. Oversees the management anddocumentation of investigational products (IP) for multiple studyteams/research program. Serves as an IP expert resource for study teams. Designs, implements, an d optimizes methods for handling IP. Provides direction to multiple study teams/research program to prepare for study monitoring and audit visits. Maintains participant level documentation for all studies, including tho se that are complex in nature (e.g., procedural and interventionalstudie s) and/or require access to the Duke EHR. May train or oversee others.Se rves as an expert resource for multiple study teams/research program for participant retention. Liaises with other resources at Duke to optimize retention rates. Develops and oversees the implementation of strategies for meeting recruitment goals for the research program(s). Provides training.Serves as an expert to research program team members in the area ofsc reening. May provide oversight andconduct training in this area. Develops, oversees adherence, and trains in the use and development of SOPs across research portfolio. May provide input for institutional SOPs. Creates, optimizes, and oversees the systems formanaging specimens for multiple study teams/research program. Serves as anexpert resource and trainer in specimen collection, processin g, preparation,shipping and maintenance. Maintains study level documenta tion 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. Serves as an expert resource and trainer to multiple study teams/research program for preparing and con ducting complex study visits, developing tools, and implementing operational plans. Leads team meetings and facilitates healthy communication between staff. Ensures good communication across multiple study teams, and mentors staff to improve communication strategies.

Ethics:
Ensures that multiple study teams/research program team members are appropriately identifying and documenting adverse event information. Provides oversight and training to multiple study teams/research program team members who conduct and document consent for participants for all types of studies, including those that are complex in nature and/or require any orders in MaestroCare. May serve as an expert resource with regard to conducting and documenting consent including liaising with and being knowledgeable about other resources at Duke. Provides oversight and training to multiple study teams/research program team members who develop the consent plan and document. Serves as an expert resource with regard to developing consent plans and documents for participants in a variety of studies. Provides oversight and training to multiple study teams/research program team members who develop and submit documentation and information for IRB review. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. May train or oversee others.

Data:
Selects and implements data capture methods appropriate fo r the researchprogram. Serves as an expert indesigning ECR Fs and EDCs to collect data according to protocols and researchprogram p rocesses. Oversees the process of QA, data corrections, and queriesused within multiple study teams/the research program, including creating and using QA protocols, queries, summaries, and reports. Recog nizes trends, and recommends strategiesto improve processes or retrain s taff. Serves as an expert data corrections,queries, and quality assuranc e resource, including liaising with and beingknowledgeable about other r elated resources at Duke. Assists multiple studyteams in developing prot ocols that include strategies and processes to ensuredata security and p rovenance. Recommends and leads implementation of improved processes, policies, and systems to ensure data security and data provenance. Serves as an expert resource to multiple study teams/research program with regard to mapping data flow. Predicts areasof vulnerability in th e data flow plan. Determines areas where data provenance ma y be compromised, and helps study teams/research program staff work through solutions. Ensures that study teams are familiar with data flow resources at Duke. Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for multiple research teams /research program, as relevant.

Science:
Independently dev elops funding proposals and grants, including leading thedrafting of research aims, background, methods, etc. Independently conductsliterature earches and reviews. Independently develops protocols for complex investigator-initiated studies, across multiple PIs or study teams. 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:

Mentors, trains, and oversees activities related to how teams communicate withsponsors and/or CROs. Oversees activities related to site visits. Oversees use of systems and system reports to manage research participants' activities and tracking/marking financial milestones. Oversees use of systems and system reports to manage research protocol activities and maintaining current protocolinformation.Makes feasibility recommendatio ns for multiple studyteams/research program. Develops and oversees processes to determine participation in trials. For studies with complex supplies or equipment, ensures that there are ample supplies and thatequipment is in good working order. May forecast staffing needs. May train oroversee others. Works with the CRU or departmental leadership to ensure thatstudies within the research program are conducted in compliance with institutional requirements and policies. Oversees implementation of operational plans across research program, including at multiple sites. Develops and implements closeout procedures for multiple studies across multiple teams.

Leadership:
Encourages staff to take part in professional development opportunities. Keepscurrent with research updates and advances in the scientific area, considersthe impact on the broad research portfolio, and oversees necessaryimplementation. Serves in a leadership capacity with internal and externalgroups (e.g., speaks at events, leads institutional initiatives or committees).Develops and implements solutions at the institutional level to improve theresearch process. Uses expertise and acumen to influence change at thedivision, de partment, or CRU level. Demonstrates resilience and actively facilitates the research program through change. Uses advanced subject matterexperti se in the therapeutic area or clinical research to solve problems across multiple study teams. Trains others to communicate effectively within teams. Facilitates resolution of issues associated with teams or communication.

Minimum Qualifications
Education
Work requires an Associate's degree

Experience
Work requires a minimum of six years of research experience. A Bachelor's degree may substitute for 2 years required 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.