CLINICAL RESEARCH SPECIALIST, SR - CTSI
CLINICAL RESEARCH SPECIALIST, SR - CTSI
Duke Translational Medicine Institute
Perform 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 Trials Project Leader in the CTSI Translational Population Research office in Kannapolis, NC. Participate in day-to-day operations related to the collection, compilation, and documentation of clinical research data.
1. Clinical research operations. Screen, schedule, conduct visits, and consent participants in minimal risk studies, including documentation of consent in the electronic medical record; may conduct these activities for studies with greater than minimal risk under supervision. Prepare documents, equipment, or supplies for research visits. Conduct and document visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments, and Standard Operating Procedures (SOPs). Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks. Collect, prepare or process adverse event information under supervision. Provide input for adverse events reports. Assist with maintenance of study level documentation. Prepare for study monitoring or study audit visits. Study visits may occur at the CTSI Translational Population Research office or at other various sites in the community. Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs. Initiate telephone interviews for the purpose of recruitment, screening, scheduling and/or collect follow up data. Recruitment activities may include working at various community events. Participates in select quality control measures related to participant recruitment, screening, self- report questionnaires, and reimbursement to assure that protocol guidelines are adhered to as well as ICH and FDA guidelines. Provide input for DUHS Institutional Review Board documents such as consent forms, protocols, and continuing reviews. Assist with management of Investigational Products including arrival, storage, handling including requesting requisitions, inventory, and reordering
2. Ethical and participant safety considerations. Maintain familiarity 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 and train others in Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations. 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 with the development of data collection documents to standardize process Map a protocol's data flow plan; including data capture, storage, management, quality, and preparation for analysis. Candidate needs to be able to perform a variety of responsibilities unsupervised and must be self- motivated. Candidate must also be able to work flexible hours, including occasional evening and weekend hours. Candidate must be comfortable working in busy (clinical and non-clinical) settingsand must be able to lift and move necessary study equipment on occasion (lift greater than 25 lbs). Independently investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data; follow and assist with development of SOPs for data quality assurance. Run summaries and reports on existing data. Use required processes, policies, and systems to ensure data security and data provenance. Recognize and report vulnerabilities related to security of physical and electronic data.
4. Scientific concepts and research design. May conduct literature reviews under the direction of the CRC or PI. Identify various stakeholders (statistical, operational, etc.) to ensure adequate 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 improving process. Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. Maintain Duke and project specific training requirements. May serve as mentor to other staff.
6. Study and site management. Participate in sponsor-required training. Maintain inventory and quality of study supplies and equipment. Prepare items for site initiation visits, and take part in visits as requested/directed. Assist with the development of protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms.
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. Communicateand 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.
803 CLINICAL RESEARCH SPECIALIST, SR
Job Family Level
Full Time / Part Time
Regular / Temporary
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.
Work requires an associates degree.
One year of relevant experience (e.g., research, clinical, interaction with 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.