CLINICAL RESEARCH SPECIALIST
- Location: Durham, NC
- Posted: Oct 4, 2019
School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nations 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.
Perform a variety of research, data, and clerical duties of a routine and technical nature to support the conduct of clinical research, under the direction of a Clinical Research Coordinator or similar CRU/Oversight Organization designee.
1.Clinical research operations. Identify participants that meet eligibility requirements under the supervision of a CRC/CRNC. Document in record. Schedule participants for study visits as directed. Prepare necessary documents, equipment, supplies, etc. Conduct and document visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments, and Standard Operating Procedures (SOPs) for minimal risk studies or for other studies under direction. Maintain subject level documentation for minimal risk studies, or for other studies under direction. Follow procedures and documentation of study payment. Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs. Assist with maintenance of study level documentation.
Collect, prepare, process, ship, and maintain inventory of research specimens. Provide input for adverse event reports. Collect, prepare or process adverse event information under supervision. Assist with preparation of study monitoring and audit visits.
2.Ethical and participant safety considerations. Be familiar with the ethical conduct of research, and safeguards needed when conducting research with vulnerable populations. Understand that the safety of research participants is a priority.
3.Data management and informatics. Use Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations with little assistance. Enter data accurately. Score tests and measures according to protocol, and appropriate to role. Complete paper and electronic Case Report Forms (CRFs and eCRFs) accurately and according to protocol.
Assist in investigating incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data; follow SOPs for data quality assurance. Use required processes, policies, and systems to ensure data integrity, provenance, and security.
4.Scientific concepts and research design. Conduct literature reviews under the direction of the CRC, CRNC, or PI.
5.Leadership and professionalism. Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. Maintain Duke and project specific training requirements.
6.Study and site management. Prepare items for site initiation visits. Participate in sponsor required training.
7.Communication and team science. Participate in study team meetings. Respond to routine questions related to study protocol and refer more complex questions to others as appropriate. Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution. Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively.
Perform other related duties incidental to the work described herein. The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Required Qualifications at this Level
Work requires an associates degree.
None above education listed above
Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).
Duke University 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 ideasan 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 essential job 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.