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.
Provide leadership and coordination in the conduct of multiple, complex oncology clinical trials and research studies including Investigational Products [IP] for the Duke Cancer Institute's [DCI] Center for Cancer Immunotherapy [CCI].
The CCI will work with the DCI's clinical research teams to develop research concepts and clinical trials and provide education throughout the DCI. The goal of the Center is business development, investigator initiated trials [IITs], initiating funding applications, and developing manufacturing and support for cellular products.
Operations, Study and Site Management
Employ strategies to maintain recruitment and retention rates, and assist participants with individual needs. Collect information to determine appropriate study feasibility, recruitment and retention strategies. 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.
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.
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. Monitor financial study milestones and report appropriately. Coordinate with financial teams and participate in budget development. Assist with study budgets and closeouts.
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.
Use Electronic Data Capture [EDC] systems and enter data accurately. Detect issues related to data capture, collection or management and suggest solutions.
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.
Actively network. Provide leadership within the team. Actively participate in team meetings, committees, task forces and ad hoc groups.
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.
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.
Basic Life Saving [BLS] certification from the American Heart Association or Duke approved equivalent course is a requirement of this position.
Other work as assigned.
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Qualifications Required At This Level
Completion of an Associate degree.
Work requires a minimum of two years of relevant research experience. A Bachelor degree may substitute for 2 years required experience.
Can easily use computing software and web-based applications [e.g., Microsoft Office products and internet browsers].
The preferred candidate will have oncology or research experience, training, education or clinical trials coordination 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.