CLINICAL RESEARCH SPECIALIST, SR
CLINICAL RESEARCH SPECIALIST, SR
General Internal Medicine
Type of Research:
The primary role of this position is to assist investigators with literature reviews, preparation of proposals, manuscripts, abstracts, presentations, and materials for research studies. Some assistance with screening, conducting study visits, consenting research participants and data entry is also needed under the supervision of PI(s) and senior research staff.
Conduct literature reviews under the direction of the CRC, PI or other senior level staff. Assist investigators with formatting of tables and documents for proposals, manuscripts, abstracts, presentations, etc. Summarize study results. Assist with preparation of study related documents such as research summaries, surveys, consent forms, protocols, and SOPs under supervision of investigators/senior research staff.
Screen participants for minimal risk studies. May screen participants for studies with greater than minimal risk, under supervision. Maintain subject level documentation for all studies independently Schedule participants and conduct visits for minimal risk studies independently. Collaborate to maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc. Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs. Evaluate processes to identify issues related to recruitment and retention rates. Conduct and document consent for participants in minimal risk studies. May conduct consent for studies with greater than minimal risk, under the supervision of a CRC or CRNC. Prepare for study monitoring and study audit visits. Collect, prepare or process adverse event information under supervision. Provide input for adverse event reports Provide input for DUHS IRB documents such as consent forms, protocols, and continuing reviews.
Communicate to research participants, both orally and written, the difference between clinical activities and research activities in all study documents and research participant communications. 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.
Train others on study team in use of technologies and software, and in completion of ECRFs. Assist with the development of data collection documents to standardize process. Use EDC systems and enter data accurately. 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. Run summaries and reports on existing data. Assist with development of and follow SOPs for data quality assurance.
Encourage and support colleagues in completing project work. Assist research colleagues in identifying efficiencies and improving process. May serve as mentor to other staff. Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. Maintain Duke and project specific training requirements.
Study and Site Management:
Prepare items for site initiation visits. Participate in sponsor required training. Assist with the development of protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms.
Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively. 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.
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).
Education: Bachelors degree required.
Experience: One year of relevant experience (e.g., research, literature reviews, interaction with study population)
Skills: Fluent in Microsoft Office products (Word, Excel, Powerpoint, etc) and internet browsers; Excellent communication skills; Excellent writing skills.
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.