Description
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.
Work Performed
Operations
Under supervision, assists with managing investigational products including arrival, storage, and handling (requisitions, inventory, and reordering). Under supervision, prepares for study monitoring and audit visits. Under supervision, may document some participant-level information for non-complex (e.g., questionnaire, data registry, scripted) studies outside of the EHR. Follows SOPs and strategies to manage and retain research subjects. Recruits research participants according to study protocol. Under supervision, collects information from sources including the EHR to assist study team in determining eligibility. Follows SOPs. Under supervision, employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Assists with establishing and maintaining study level documentation. Prepares documents, equipment, supplies, etc. in compliance with the protocol. Assists with the conduct and documentation of non-complex visits and scripted testing or interviews. Participates in study team meetings.
Ethics
Under supervision may collect information about AEs, identified in the protocol or investigator brochure. Conducts and documents consent for participants in non-complex studies. These are typically repositories, survey studies, simple observational studies and non-patient studies that do not involve investigational products or devices. Cannot consent for any studies that involve investigational products or devices or require clinical research orders in Maestro Care (i.e., electronic health record). 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.
Data
Under direct supervision from Biostatistician and PI may perform basic analyses on structured data. Enters and collects basic data for research studies. May score scripted or validated tests and measures. With supervision, responds to queries created by a CRO or the data manager. May assists with quality control and data cleaning as directed. Under supervision, corrects and documents incomplete, inaccurate or missing data for non-
complex studies. Follows SOPs for quality assurance. Follows required processes, policies, and systems to ensure data security and provenance. Follows predetermined SOPs to assist in documenting and maintaining documentation to facilitated data sharing. Knowledgeable about the use of data standard policies. Under supervision, performs de-identification on allowable data to Safe Harbor standards. Learns and uses new technology when required. Under supervision, assists in preparing tables, data visualizations, and lay summaries to communicate study results to participants. Assists in updating reports on study progress for the PI and other study team members and collaborators. Under supervision, executes predetermined testing scripts after the completion of a build, or following any project changes or system upgrades.
Science
- May assist with simple literature searches under supervision from PI or CRC. Demonstrates a basic understanding of the elements of research study designs.
Study and Site Management
- As directed, attends or schedules site visits. Records participant accrual information and consent documentation for non-complex studies in clinical research management system.
- Records basic protocol information in clinical research management system. 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).
Leadership
- Maintains Duke and project specific training requirements. Keeps current with research updates by attending key external departmental meetings (i.e. Research Wednesday, RPN, additional training, etc.). 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. Communicates with other study personnel as required for study implementation and routine problem resolution.
The primary duties for this position are related to
- Assist in screening eligible healthy controls and patients to participate in EEG research studies.
- Under supervision, maintain and populate database, including but not restricted to patients' information, EEG recordings, meta data and general annotations.
- Assist with codebase maintenance and documentation
- Prepare documents, equipment and supplies for research studies in compliance with study protocols.
- Provide support for Anphy lab projects, e.g. technical support through to helping to prepare articles for publication.
- Follows required processes, policies, and systems to ensure data quality and security.
- Participates in weekly lab meetings and journal clubs.
Special skills
- The candidate needs to be organized and have experience in data collection, maintenance and documentation.
Required Qualifications at this Level
Education/Training
- Work requires an Associate's degree.
Experience
- One year of relevant experience. A Bachelor's degree may substitute for required experience.
