CLINICAL RESEARCH SPECIALIST, SR
CLINICAL RESEARCH SPECIALIST, SR
DUKE EARLY PHASE RESEARCH UNIT
Perform a variety of research, data, and clerical duties of a routineclinical research data.and technical nature to support the conduct of clinical research underthe supervision of a ClinicalResearch Coordinator or similar CRU/Oversight Organization designee at Duke Early PhaseClinical Research Unit. Participate in day-to-day operations related tothe collection, compilation,and documentation ofWork Performed1.Clinical research operations. Screen, schedule, conduct visits, andPerform other relatedduties incidental to the work described herein.required of personnel soclassified.intended to be an exhaustive list of all responsibilities and dutiesThe above statements describethe general nature and level of work being performed by individuals assigned to this classification.This is not consent participants in minimal risk studies, includingdocumentation of consent in the electronic medical record; may conduct these activities for studieswith greater than minimal risk under supervision.
Prepare documents, equipment, or supplies forresearch visits. Conduct and document visits and protocol-specific testing/interviews according tostudy protocol, operationalplans of clinical departments, and Standard Operating Procedures(SOPs). Employ strategies tomaintain recruitment and retention rates, and to assist participantswith individual needs. Collect,prepare, process, ship, and maintain inventory of research specimensand train others in these tasks. Collect, prepare or process adverse event information under supervision. Provide input foradverse events reports. Assist with maintenance of study leveldocumentation. Prepare for study monitoring or study audit visits.Provide input for DUHS Institutional Review Board documents such asconsent forms, protocols,and continuing reviews. Assist with management of Investigational Products including arrival,storage, handling includingrequesting requisitions, inventory, and reordering
2.Ethical and participant safety considerations. Maintain familiaritywith the ethical conduct ofresearch and safeguards needed when conducting research with vulnerablepopulations.Understand that the safety of research participants is a priority.
3.Data management andinformatics. Use and train others in Electronic Data Capture (EDC)systems, technologies, andsoftware necessary for study operations. Enter data accurately. Scoretests and measures according to protocol and appropriate to role.Complete paper and electronicCase Report Forms (CRFs and eCRFs) accurately and according toprotocol. Assist with thedevelopment of data collection documents to standardize process Map aprotocol's data flow plan;including data capture, storage, management, quality, and preparationfor analysis. Independentlyinvestigate incomplete, inaccurate, or missing data/documents to ensureaccuracy andcompleteness of data; follow and assist with development of SOPs fordata quality assurance. Runsummaries andreports on existing data. Use required processes,policies, and systems to ensuredata security and data provenance. Recognize and report vulnerabilitiesrelated to security ofphysical and electronic data.
4.Scientific concepts and research design. May conduct literaturereviews under the direction ofthe CRC, CRC-RN, or PI. Identify various stakeholders (statistical,operational, etc.) to ensureadequate design, implementation, and testing of study aims.
5.Leadership and professionalism.Encourage and support colleagues to complete project work.Assist research colleagues in identifying efficiencies and improvingprocess. Recognize andemploy the professional guidelines and code of ethics related to theconduct of clinical research.Maintain Duke and project specific training requirements. May serve asmentor toother staff.
6.Study and site management. Participate in sponsor-required training.Maintain inventory andquality of study supplies and equipment. Prepare items for siteinitiation visits, and take part invisits as requested/directed. Asist with the development ofprotocol-specific systems anddocuments including process flows, training manuals, standard operatingprocedures, and casereport forms.
7.Communication and team science. Participate in study team meetings.Respond to routinequestions related to study protocol and refer more complex questions toothers as appropriate.Communicate and coordinate with other study personnel as required forstudy implementation androutine problem resolution. Write and speak clearly in a variety ofsettings and styles to conveymessages and ideas effectively.Knowledge,Skills and AbilitiesCan easily use computing software and web-based applications (e.g.,Microsoft Office productsand internet browsers).
803 CLINICAL RESEARCH SPECIALIST, SR
Job Family Level
Full Time / Part Time
Regular / Temporary
Duke University is an Affirmative Action/Equal Opportunity Employercommitted to providing employment opportunity without regard to anindividual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion,sexual orientation, or veteran status.Essential Physical Job Functions:Certain jobs at Duke University and Duke University Health System mayinclude essential job functions that require specific physical and/ormental abilities. Additional information and provision for requests forreasonable accommodation will be provided by each hiring department.
Work requires an associates degree.
One year of relevant experience (e.g., research, clinical, interactionwith study population, program coordination).
Auto req ID
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
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.