CLINICAL RESEARCH COORDINATOR
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.
Duke Aging Center
Occupational Summary: The Clinical Research Coordinator (CRC) will join a growing research team working on studies led by investigators in the Duke Center for Aging, the Department of Neurology, the Division of Geriatrics, and the Duke Center for Research to Advance Healthcare Equity. Ongoing studies are focused on community engagement and healthcare equity, Alzheimer’s Disease and related neurocognitive disorders, and others. This position will involve working with collaborators at multiple sites and may require travel between clinics and offsite locations. Preferred Skills: The ideal candidate will:
- Possess excellent verbal and written communication skills
- Possess human subject clinical research and regulatory experience
- Exhibit familiarity or ease communicating and relating to older adults
- Possess experience or interest in community engagement research
- Possess effective recruitment and retention skills
- Demonstrate the ability to plan and prioritize workload to meet deadlines, while planning and tracking status on several projects
- Be willing to be flexible in order to accomplish the shared goals of projects
- Demonstrate flexibility and willingness to acquire new skills
- Showcase their proven ability to work both independently and within a team with excellence, dignity, and respect
- Experience with Maestro Care and OnCore preferred
- Phlebotomy experience preferred
- Screen participants independently. Demonstrate understanding of study protocols and the ability to translate into project logistics.
- Independently conduct and document consent for participants in all studies, including those that are complex in nature/clinically relevant and/or require access to the EHR for documentation.
- Prepares for, coordinates, and actively participates in site visits.
- Administer cognitive and mobility tests questionnaires to study participants.
- Maintain subject level documentation. Schedule participants and conduct study visits independently.
- Assist with the development of, and follow, protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms.
- Ensure that there are ample study supplies and that equipment is in good working order.
- Collect, prepare, process, deliver, and maintain inventory of research specimens.
- Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs. Evaluate processes to identify issues related to recruitment and retention rates.
- Ensure participant care expenses have appropriate financial routing in a timely manner. May monitor financial study milestones and report appropriately. Coordinate with financial teams, PRMO, etc. and participate in budget development as appropriate.
- 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.
- Maintain study's compliance with institutional requirements and other policies
- Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties.
Take part in site initiation and closeout meetings independently.
- Prepare studies for closeout and document storage.
- May train or oversee others.
- Successfully 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 or data entered into OnCore.
- Work with the study team to develop DUHS IRB documents such as consent forms, protocols, and continuing reviews.
- Maintain protocol specific training requirements and develop solutions to proactively ensure study team members' compliance with these training requirements.
- Responsible for adherence to clinical research policies to ensure ethical conduct and protect vulnerable populations. Understand that the safety of research participants is a priority.
- Assist with the development of Conflict of Interest (COI)/Data Safety Monitoring Plans (DSMPs)/Research Data Security Plans (RDSPs) and Clinical Quality Management Plans (CQMPs) and ensure study team compliance.
- Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research.
- Develop and submit documentation and information for Institutional Review Board (IRB) review. Communicate with the IRB staff and reviewers and handle issues appropriately.
- Identify all adverse events (AEs), and determine whether or not they are reportable. Collaborate with the PI to determine AE attributes, including relatedness to study.
- Prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies.
- Responsible for adherence to clinical research policies to ensure ethical conduct and protect vulnerable populations.
- Communicate to research participants the difference between clinical activities and research activities, and the risks and benefits of study participation.
- Use EDC systems and enter data accurately and may train others in these tasks. Detect issues related to data capture, collection or management and suggest solutions.
- Use required processes, policies, and systems to ensure data security and provenance. Recognize and report vulnerabilities related to security of physical and electronic data. Independently investigate incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data. Run summaries and reports on existing data.
- Assist with development of and follow SOPs for data quality assurance.
- Recognize when data agreements are necessary.
- Proactively seek opportunities to add relevant skills and certifications to own portfolio.
- Keep current with research updates by attending key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.) and apply the learned material to the job.
- May disseminate information to others.
- Serve on committees and workgroups internal to Duke or externally in therapeutic area of research.
- Demonstrate interpersonal skills to get work done efficiently.
- Recognize and escalate organizational issues that could be optimized to improve research processes.
- Demonstrate resilience and is adaptive to change.
- Use advanced subject matter expertise in the therapeutic area or clinical research to solve problems.
- Communicate effectively with others, regardless of reporting relationship, to accomplish shared work objectives.
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.
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