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.
Participate in or lead day-to-day opera tions of clinical research studiesconducted by Duke Global Digital Heal th Science Center; perform a variety of duties involved in the collectio n, compilation, documentation, and analysis of clinical research data.
Note: This is a 1-year grant-fun ded, term limited position, contingent upon continued funding.
1. Research Operations. -20%
Knowledgeable in regulatory and institutional policies and processes; applies appropriate ly in study documentation, protocol submissions, and standard operating procedures(SOPs).
· Screen, enrolls and supports participants for complex studies.
· H elps develop SOPs.
· Employs and may develop strategies to maintain recruitment and retention rates and evaluate processes to identify problems.
· Conducts and plans for visits for complex studies.
· Maintains participant level and study level documentation for all studies, including those that are complex in nature and/or require access and comfort with the Duke electronic healt h record (EHR), and research management systems such as iRIS(IRB system) , OnCore, REDCap, and study-specific sites.
· Collects, prepares,processes, ship s, and maintains the inventory of research specimens, primarily those re quiring complex procedures.
2. Safety and Ethics. -10%
· Conducts and documents consent for participants for al l types of studies, including those that are complex in nature and/or re quire any orders in Maestro Care.
· Develops consent plans and documents for pa rticipants in a variety of studies.
· Develops and submits documentation and in formation for Institutional Review Board (IRB)review. Communicates with the IRB staff and reviewers and handle issues appropriately. Identifies all adverse events (AEs), and determines whether ornot they are reporta ble. Collaborates with the PI to determine AE attributes,including relat edness to study.
· Prepares and submits documents needed for regulatory and saf ety reporting to sponsors and other agencies.
· Responsible for adherence to cl inical research policies to ensure ethical conduct and protect vulnerabl e populations.
· Communicate to research participants the difference between cl inical activities and research activities, and the risks and benefits of study participation.
3. Data. - 25%
· Enters and collects data, and develops data entry or collection SOPs or to ols.
· Ensures accuracy and completeness of data for all studies.
· Recognizes data qu ality trends and escalates as appropriate.
· Recognizes and reports security of physical and electronic data vulnerabilities.
· Independently uses and impleme nts technology to enhance productivity or process.
4. Scientific Concepts. -30%
· Assists wi th or contributes to the development of funding proposals.
· Using scientific p roposals from the PI, develops research protocols.
· Demonstrates a basic under standing of the elements of research study designs.
· Independently conducts li terature searches and reviews.
· Contributes to the development of scientific p ublications or presentations and serves as an author on poster presentat ions or publications.
5. Site an d Study Management. -10%
· Ensures that studies are conducted in compliance with institutional requirements and otherpolicies.
· Follows protocol-specific sys tems and documents including process flows.
· Prepares for,coordinates, and act ively participates in site visits.
· Communicates effectively with sponsors and /or contract research organizations (CROs).
· Prepares studies for closeout and document storage.
6.Leadership a nd professionalism. -5%
· Proactively seeks opportunities to add relevant skills and certifications to own portfolio.
· Keeps current with research updates by attending key external offerings (i.e. Research Wednesday,RPN, events ou tside of Duke, etc.) and applies the learned material to the job.
· Navigates pr ocesses and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to getwork done efficiently.
· Demonstrates resilience and is adaptive to change.
· Comm unicates 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.
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.
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.
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