Senior Clinical Research Specialist
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 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 and train others in these tasks.
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
Assist with maintenance of study level documentation.
Define source document.
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.
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.
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.
Assist with the development of Conflict of Interest (COI)/Data Safety Monitoring Plans (DSMPs)/Research Data Security Plans (RDSPs).
Assist with the coordination of efforts of external monitoring boards.
Identify and the explain the risk and benefits to a subject as these pertain to your clinical trial
Map a protocol's data flow plan: data capture, storage, management, quality, and preparation for analysis
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.
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.
Conduct literature reviews under the direction of the CRC, CRNC, or PI Identify various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of study aims.
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:
Collect information to determine appropriate feasibility, recruitment and retention strategies.
Maintain study's compliance with institutional requirements and other policies (e.g., NIH Public Access policy, ct.gov, Research Data Security Plans, Social Media policy, etc.).
Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties.
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.
Prepare for closeout and document storage
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:
Portfolio Management (Effort %):
• Other: Type of Research This position will support NAFLD (Non-alcoholic Fatty Liver Disease) research under the direction of the Program Director.This position will consent to minimal risk studies independently and support other Clinical Research Coordinators with greater than minimal risk studies. This position does not have a supervisory role.
Special Skills n/a
Requisition Number 401500190
Duke Entity MEDICAL CENTER
Job Code 803 CLINICAL RESEARCH SPECIALIST, SR
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/ormental 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).
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