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adzuna-us  |  United States  |  

United StatesMallard Ave, NC, 27701
Education/Teaching & Tutoring
Work Type:
Work Time:
Full Time


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

Facilitates the process by coordinating with study teams and appropriate Duke offices.

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).

May train or oversee others.

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.

Independently navigates conversations with foreign agencies and study teams to develop or obtain the required documentation for compliance with international regulations.

May assist others with ensuring regulatory compliance with international studies.

Oversees the management and documentation of investigational products (IP) for multiple study teams/research program.

Serves as an IP expert resource for study teams.

Designs, implements, and optimizes methods for handling IP.

Participates in or leads development of monitoring and audit training sessions and/or policies and guidelines for research program.

Serves as an expert resource to address and correct findings.

Maintains participant level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies) and/or require access to the Duke EHR.

May train or oversee others.

Employs strategies to maintain retention rates.

Evaluates processes to identify problems with retention.

May train or oversee others.

For multiple study teams, develops and oversees the implementation of strategies for meeting recruitment goals.

Provides training.

Serves as an expert to research program team members in the area of screening.

May provide oversight and conduct training in this area.

Develops or helps develop SOPs.

May train or oversee others.

Collects, prepares, processes, ships, and maintains the inventory of research specimens, primarily those requiring complex procedures.

May train or oversee others.

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.

May train staff.

Leads team meetings and facilitates healthy communication between staff.

Ensures good communication across multiple study teams, and mentors staff to improve communication strategies.

Ethics: Serves as an expert in AE identification and documentation, including liaising with and being knowledgeable about other resources at Duke.

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 Maestro Care.

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.

Provides oversight and training to multiple study teams/research program team members who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies.

Data: 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.).

May train or oversee others.

Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for multiple research teams/research program, as relevant.

Science: Study and Site Management: Mentors, trains, and oversees activities related to how teams communicate with sponsors 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.

Makes feasibility recommendations for multiple study teams/research program.

Develops and oversees processes to determine participation in trials.

Oversees the research resources and/or finance processes for a broad research portfolio.

Works with central offices to optimize process.

Works with the CRU or departmental leadership to ensure that studies within the research program are conducted in compliance with institutional requirements and policies.

Follows, and may develop or implement, protocol-specific systems and documents including process flows.

May train or oversee others.

Prepares studies for closeout and document storage.

May train or oversee others.

Leadership: Evaluates and implements the department, CRU, or division professional development and/or training programs to ensure they meet the needs of staff retention, continuous improvement, and development.

Keeps current with advances in the scientific area and considers the impact on the research program.

Keeps self and team current with research updates by attending external offerings; applies learned material on the job.

Plays key/leadership role on committees and workgroups.

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 implemimplements solutions that work within the existing leadership or organizational structure.

Demonstrates resilience, leadership, and actively facilitates change for research portfolio.

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.

Type of Research: Busy Heart Failure Cluster in the Heart Center.

Will manage 5 staff.

Needs to manage research and finance portfolio.

Heavy in IND w industry and federal projects.

Special skills: History of management is a plus Required Qualifications at this Level Education/Training 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.