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.
Clinical Research Coordinator
Division of Nephrology
Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study submission and conduct.
Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties.
Serves as the primary liaison with sponsors, IDS, and other parties as necessary.
May develop resources and tools for study management, and/or coordinate with other entities or offices.
Responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research participants.
Prepares for and provides support for study monitoring and audit visits, including support for the reviewer; addresses and corrects findings.
Maintains study level and 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.
Evaluates processes to identify problems with recruitment and retention and employs strategies to improve/maintain recruitment and retention.
Screens participants for complex studies (e.g., procedural and interventional studies).
Collects, prepares, processes, ships, and maintains the inventory of research specimens, primarily those requiring complex procedures.
Conducts and plans for complex study visits.
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).
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.
Identifies all AEs, and determines whether or not they are reportable.
Collaborates with the PI to determine AE attributes, including relatedness to study.
Communicates with the IRB staff and reviewers and handles issues appropriately.
Prepares and submits documents needed for regulatory and safety reporting to IRB, sponsors and other agencies.
Collects and enters data.
Develops data collection/data entry/data quality assurance SOPs and tools.
Ensures accuracy and completeness of data for all studies, including those that are complex in nature.
Recognizes data quality trends and escalates as appropriate.
Develops and implements protocols for research program that include strategies and processes to ensure data security and provenance.
Serves as an expert data provenance and security resource, including liaising with and being knowledgeable about other related resources at Duke.
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.
Demonstrates a basic understanding of the elements of research study designs.
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.
Study and Site Management:
Prepares for, coordinates, and actively participates in site visits.
Communicates effectively with sponsors and/or CROs.
Communicates regularly with Investigators and Team Lead providing updates on recruitment goals, operational workflow efficiencies, budget accountability and projected expenses.
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 workflows.
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.
May disseminate information to others; may train others regarding CRC responsibilities
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 engages 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.
Special skills: Position requires excellent communication skills, ability to travel independently to sites, and function autonomously as well as with teams. Prefer candidate with nephrology, dialysis, or internal medicine experience.
Minimum Qualifications Education
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.
As a world-class academic and health care system, Duke Health strives to transform medicine and health locally and globally through innovative scientific research, rapid translation of breakthrough discoveries, educating future clinical and scientific leaders, advocating and practicing evidence-based medicine to improve community health, and leading efforts to eliminate health inequalities.