2024-05-16
AppCast (https://www.appcast.io)
Other
/yr
full-time
employee
Durham
North Carolina
27703
United States
School of Medicine
Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.
Clinical Research Coordinator (CRC)
Oncology Clinical Research Unit [CRU]
Cancer Patient Experience Research Program [CPEP]
Position Description
Occupational Summary
Provide leadership and coordination in the conduct of research studies focused on cancer patients' experiences and palliative care research for the Duke Cancer Institute's [DCI] Cancer Patient Experience Research Program [CPEP]. The Oncology Clinical Research Unit [CRU] oversees the conduct of research. CPEP primarily focuses on research pertaining to cancer patients' experiences and palliative care research. The research performed is both original and sponsored, utilizing quantitative, qualitative, or mixed-method. The majority of the studies are minimal risk.
Contributes to study design conversations both individually and as part of the team. The work includes data collection and documentation of cancer patient experience studies, including patient reported outcome (PRO) and real-world evidence (RWE) studies, patient screening, recruitment, consent, data collection, and study participant interactions and contact.
Each team member is expected to work independently, but also assist one another when needed. The team encourages the sharing of ideas and expertise, and fosters an environment that is centered on the research patients, as well as the integrity and science of the research. Individuals that are team-oriented, yet who regularly and independently seek ways to increase their research abilities, and who are open to learning new electronic systems are encouraged to apply.
Work Preformed
Operations, Study and Site Management - 55% Effort
This hybrid position will require the individual to employ and develop research strategies for screening and recruitment, maintain recruitment and retention rates, and assist participants with individual needs. Collect information to determine appropriate study feasibility, recruitment and retention strategies. Develop consenting plans. Evaluate processes to identify issues related to recruitment and retention rates; offer solutions.
Work closely with the Principal Investigator [PI] and study team to recruit, screen and enroll participants for studies. Conduct and document consent for study participants. Schedule participants and conduct visits for studies; conduct and document visits.
Coordinate study activities with teammates and colleagues to successfully implement and conduct the study. Recognize and offer solutions to study problems. Escalate issues appropriately. Take part in site initiation and closeout visits. Assist in the development of new studies. Develop resources and tools for the management of assigned studies.
Maintain study's compliance with institutional requirements and policies. Maintain appropriate study-level documentation including regulatory binders, enrollment logs, and patient registration in the system of record. Record adverse events [AE] and report promptly. Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties. Develop and submit documentation and information to the Institutional Review Board (IRB).
Assist with the development of Conflict of Interest [COI], Data Safety Monitoring Plans [DSMPs], and Research Data Security Plans [RDSPs]. Assist with the coordination of external monitoring boards.
Follow procedures and documentation of study payment and participant care expenses in a timely fashion. Manage participant payments. Monitor financial study milestones and report appropriately. Coordinate with financial teams and participate in budget development. Assist with study budgets and closeouts.
Data - 25% Effort
Use Electronic Data Capture [EDC] systems and enter data accurately. Ensure accuracy and completeness of data for all studies. Develop data collection and capture tools. Assist with the design of and administer electronic surveys and questionnaires. Independently utilize and implement technology to enhance productivity and processes.
Develop and review Research Data Security Plans (RDSPs) for assigned study protocols.
Comply with required processes, policies, and systems to ensure data security and provenance. Recognize and report vulnerabilities related to security of physical and electronic data. Assist in investigating incomplete, inaccurate or missing data and documents to ensure accuracy and completeness of data. Detect issues related to data capture, collection or management and suggest solutions.
Communication - 10% Effort
Serve as primary liaison with sponsors, study personnel and PI for assigned studies. Collaborate, and communicate with other study personnel as required. Communicate concerns clearly in a professional manner. Respond timely to emails, phone calls and questions. Refer more complex questions and escalate issues to others as appropriate.
Assist with literature searches and reviews. Contribute to the development of research protocol sections, as assigned. Contribute to scientific publications or presentations, as requested.
Leadership - 5% Effort
Actively network. Provide leadership within the team. Actively and proactively participate in team meetings, committees, task forces and ad hoc groups. Lead meetings as assigned. Train others regarding assigned protocol tasks.
Encourage career development by actively seeking out continuing education opportunities. Participate in scientific presentations and publications.
Serve as an expert resource for colleagues and teammates. Mentor staff, including those in the same job title. Support colleagues in their project work; encourage completion.
Ethics - 5% Effort
Understand the difference between clinical trials and clinical research, and be able to demonstrate and articulate the differences in regulations that must be adhered to, as well as the differences in processes internal to Duke.
Communicate to study staff and research participants the difference between clinical and research activities, and the risks and benefits of study participations. Recognize when staff and patients are having difficulty with the distinction and work hard to help them understand the differences.
Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research.
Know and follow policies, standard operating procedures [SOPs], regulations and protocol requirements that govern clinical research. Maintain Duke and project specific training and certification requirements.
Other work as assigned.
Skills