Clinical Research Specialist, Senior
- Screen participants for minimal risk studies. May screen participants for studies with greater than minimal risk, under supervision.
- Maintain subject level documentation for minimal risk studies, or for other studies under direction.
- Schedule participants and conduct visits for minimal risk studies independently.
- Collect, prepare, process, ship, and maintain inventory of research specimens
- Describe the various steps involved in handling IP. Assist with management of Investigational Products (IP) including arrival, storage, handling including requesting requisitions, inventory, and reordering
- 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.
- Assist with addressing and correcting findings from 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.
- Identify and the explain the risk and benefits to a subject as these pertain to your clinical trial
- 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.
- Use required processes,policies, and systems to ensure data security and provenance.
- Assist in investigating incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data.
- Follow SOPs for data QA.
- 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:
- Collect information to determine appropriate feasibility, recruitment and retention strategies.
- Take part in site initiation/closeout visits as directed.
- 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.
Description of Portfolio and Clinical Responsibilities:
- Position will be assisting with gene therapy trials of patients with rare diseases seen at, or referred to Duke Center for Retinal Degenerations and Ophthalmic Genetic Diseases. Will interact with members of the CRU team and clinic staff under the supervision of the coordinator to ensure study site activation and closeout, participant recruitment/retention, visual function testing and schedule coordination of trial protocols. Experience with retinal and visual function testing and imaging techniques preferred.
Duke Entity MEDICAL CENTER
Job Family Level 09
Full Time / Part Time FULL TIME
Regular / Temporary Regular
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 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 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 Associate's degree.
One year of relevant experience.OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE