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.
- Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs.
- Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties.
- 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).
- Screens participants for complex studies (e.g., procedural and interventional studies).
- 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.
- Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies).
- Maintains study level documentation for international studies.
- Conducts and plans for complex study visits.
- May develop resources and tools for management of international studies, and/or coordinate with other entities or offices.
- Under supervision, assists with managing investigational products including arrival, storage, and handling (requisitions, inventory, and reordering).
- Prepares for and provides support for study monitoring and audit visits, including support for the reviewer; addresses and corrects findings.
- Employs strategies to maintain retention rates.
- Evaluates processes to identify problems with retention.
- Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems.
- Develops or helps develop SOPs.
- Collects, prepares, processes, ships, and maintains the inventory of research specimens, primarily those requiring complex procedures.
- Leads meetings that are multidisciplinary, including those with complex objectives.
- Identifies 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.).
- Independently uses and implements technology to enhance productivity or process.
- Assists with or contributes to the development of funding proposals.
- Independently conducts literature searches and reviews.
- Using scientific proposals from the PI, develops research protocols.
- Demonstrates a basic understanding of the elements of research study designs.
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.
- Uses 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.
- Collects appropriate information to determine whether the study team's participation in a specific trial is feasible.
- 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.
- Ensures that studies are conducted in compliance with institutional requirements and other policies.
- Follows, and may develop or implement, protocol-specific systems and documents including process flows.
- Prepares studies for closeout and document storage.
- Proactively seeks opportunities to add relevant skills and certifications to own portfolio.
- 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.
- 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.
- Demonstrates resilience and is adaptive to change.
- Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems.
- Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.
Type of Research:
This Nephrology position will recruit participants from within Duke facilities as well as various dialysis centers, and also engage community participants. Portfolio will consist of all funding types, including but not limited to industry, federal, foundation, internal sources. Study complexity will vary from simple registries to multi-site randomized clinical trials, including NIH and FDA regulated. This clinical research professional will report directly to the Nephrology Clinical Research Coordinator, Senior.
Position requires excellent communication skills, ability to travel independently to sites, and function autonomously as well as with teams.
Completion of an Associate's degree
Work requires a minimum of two years of relevant 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.