CLINICAL RESEARCH COORDINATOR - RESEARCH REGISTERED DIETITIAN
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.
The Department of Population Health Sciences is seeking to hire a Research Registered Dietitian for a NIH-funded weight management clinical trial. The Research Registered Dietitian will be responsible for delivering an evidence-based weight management program to enrolled research participants at Duke University. This position will deliver the study’s virtual intervention via leading group classes around healthy eating, dietary self-monitoring, goal setting, and relapse prevention planning. This position will work closely with a large team of investigators and research staff across multiple sites.
An ideal candidate would have experience in obesity or weight management, experience or a strong interest in adult obesity-related research and nutrition counseling (with some comfort level in cognitive-behavior therapy, motivational interviewing, and mindfulness)
Provide professional and detailed nutrition counseling to intervention groups or individuals in person, over the phone, or electronically when conducting human subjects research using the established study protocol.
Calculate and advise on individual patient nutritional needs (e.g., caloric intake)
Conduct dietary recalls or administer nutrition intake surveys using valid methods
Collaborate with other site research dietitians in developing nutrition intervention content
Train other team members to conduct dietary recalls and monitor the process for fidelity
Assist Principal Investigator and study personnel in formulating and recommending policies, plans, and procedures for the operation and application of a dietary education and research program.
Coordinate communication among research team members
Prepare materials for research team meetings and summarize meeting notes
Maintain knowledge of specific study and regulatory guidelines to ensure compliance
Supervise, orient, coordinate, and manage other members of the research team, including graduate students, research fellows, and other trainees
Utilize best practices to maintain participants in research studies (e.g., place reminder calls)
Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties.
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.
Prepares for and provides support for study monitoring and audit visits, including support for the reviewer.
Addresses and corrects 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
Follows SOPs and strategies to manage and retain research subjects.
Recruits research participants according to study protocol.
Screens participants for complex studies (e.g., procedural and interventional studies).
Assists with establishing and maintaining study level documentation.
Schedules participants for research visits (excluding those requiring EHR access).
Prepares necessary documents, equipment, supplies, etc.
Conducts and documents non-complex visits and scripted testing or interviews.
May manage participant payment.
Participates in study team meetings.
Recognizes known potential adverse events, identified in the protocol or investigator brochure, and reports to study team.
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. May train or oversee others.
Assists with the development of consent plans and documents for participants.
Under supervision, for non-complex studies (e.g., survey studies and registries), develops and submits documentation and information for IRB review.
Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies.
Enters and collects basic data for research studies.
May score scripted or validated tests and measures.
Independently corrects and documents incomplete, inaccurate or missing data for non-complex studies.
Runs summaries and reports on existing data.
Follows SOPs for quality assurance. Follows required processes, policies, and systems to ensure data security and provenance.
Learns and uses new technology when required.
This position will be responsible for data collection via patient-report and Duke’s electronic medical record. This position may also be involved in projects that involve qualitative methods and analysis.
May assist with simple literature searches under supervision from PI or CRC. Demonstrates a basic understanding of the elements of research study designs.
Clinical Research Coordinator (Research Registered Dietitian)
Provides some contribution to scientific publications or presentations
Study and Site Management
As directed, attends or schedules site visits.
Uses clinical research management system and its reports to manage research participants' activities, including minimum footprint, calendars, tracking/marking financial milestones, and all aspects of study visits. For studies with simple supplies or equipment, assists with ensuring that there are ample supplies, and that equipment is in good working order. Follows protocol-specific systems and process flows. As directed, assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor).
Maintains Duke and project specific training requirements.
Keeps current with research updates by attending key external departmental meetings
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 position will primarily be responsible for delivering an evidence-based weight management program to approximately 350 adults enrolled in an NIH-sponsored clinical trial. The weight management program includes virtual group classes and individual phone calls. Education content includes, but is not limited to, instruction around the project’s mobile applications (FitBit and MyFitnessPal) for dietary and physical activity tracking, behavioral goal setting, physical activity demonstration, weight maintenance.
This position requires a certification as a Registered Dietitian. (RD/ RDN)
Licensed Dietitian/Nutritionist (LDN) in the state of North Carolina
Master’s degree in Nutrition, Public Health, or some related field.
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.
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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.