CLINICAL RESEARCH SPECIALIST, SR
CLINICAL RESEARCH SPECIALIST, SR
Identify participants that meet eligibility requirements under the supervision of a CRC/CRNC. Document in record. Maintain subject level documentation for minimal risk studies, or for other studies under direction. 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. Follow procedures and documentation of study payment. 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. 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. Complete and submit Adverse Events Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) under supervision. 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 explain the risk and benefits to a subject as these pertain to a 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 when data agreements are necessary.
Study and Site Management:
Prepare items for site initiation visits. Participate in sponsor required training Take part in or lead closeout and document storage activities.
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.
Type of Research
The position is an assistant to the Clinical Research Coordinators in the Asthma, Allergy and Airway Center. The patient population is Asthma and COPD. The studies are complex and have challenging procedures. The assistant will process lab specimens, maintain study documentation up to standards, EDC, communicate with multiple vendors, and assist the CRCs in other administrative duties assigned.
Good organizational and prioritizing skills. Basic computer knowledge.
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.