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CLINICAL RESEARCH SPECIALIST, SR

Company: Duke Health
Location: Durham
Posted on: March 27, 2020

Job Description:

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 CenterClinical Research Specialist, Senior (CRS, Sr.) #0803Job Description--Occupational SummaryPerform a variety of research, data, and clerical duties of a routine and technical nature to support the conduct of clinical research under the supervision of a Clinical Research Coordinator (CRC) or similar CRU/Oversight Organization designee.-- Participate in day-to-day operations related to the collection, compilation, and documentation of clinical research data. This position will be working with collaborators at multiple sites and may require travel between clinics and offsite locations.----Work Performed:--OperationsScreen participants, conduct and document consent for participants in minimal risk studies. Maintain subject level documentation.-- Schedule participants for study visits. --Prepare necessary documents, equipment, supplies, and interviews according to study protocol and Standard Operating Procedures [SOPs].--Recruits research participants according to study protocol and follows standard operating procedures (SOPs) and strategies to manage and retain research subjects.Assist with the development of DUHS IRB documents such as consent forms, protocols, and continuing reviews.Responsible for adherence to clinical research policies to ensure ethical conduct and protecting 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 teams compliance. --Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research.Ensure participant care expenses have appropriate financial routing in a timely manner. Collect, prepare, process, ship, and maintain inventory of research specimens.--.Assist with the development of protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms. Prepare for closeout and document storage.--Communication:Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively. Respond to routine questions related to study protocol and refer more complex questions/issues to others as appropriate.-- Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution.-- Actively participate in study team meetings.--Data: --Use Electronic Data Capture (EDC) systems, technologies, and software to accurately enter study data.-- Complete paper and electronic Case Report Forms (CRFs and eCRFs) accurately and according to protocol. --Run summaries and reports on existing data.-- 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. Assist with development of and follow SOPs for data quality assurance. Recognize when data agreements are necessary. Recognize and report vulnerabilities related to security of physical and electronic data.--REPORTING RELATIONSHIP:-- This position will report to the appropriate Aging Center CRC or Team Lead who ultimately reports to the CRU ARPM/RPM. There will be dotted line reporting to the project specific PI for scientific/project oversight. --There may be an additional oversight relationship with study staff in other departments as needed. ----Preferred Skills: The ideal candidate will: Possess excellent verbal and written communication skillsPossess human subject clinical research and regulatory experienceDemonstrate the ability-- to plan and prioritize workload to meet deadlines, while planning and tracking status on several projectsShowcase their proven ability to work both independently and within a team with excellence, dignity, and respect--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.------Minimum Qualifications----EducationWork requires an Associate's degree.--Experience--One year of relevant experience. A Bachelor's degree may substitute for 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.

Keywords: Duke Health, Durham , CLINICAL RESEARCH SPECIALIST, SR, Healthcare , Durham, North Carolina

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