Clinical Research Specialist, SR
CLINICAL RESEARCH SPECIALIST SR.
DEPARTMENT OF OB/GYN – DIVISION OF GYNECOLOGY ONCOLOGY
- Screen participants for minimal risk studies. May screen participants for studies with greater than minimal risk, under supervision.
- 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.
- Schedule participants for study visits as directed.
- Maintain subject level documentation for minimal risk studies, or for other studies under direction.
- Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs.
- 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.
- Provide input for DUHS IRB documents such as consent forms, protocols, and continuing reviews.
- Collect, prepare, process, ship, and maintain inventory of research specimens.
- Collaborate to maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc.
- Prepare necessary documents, equipment, supplies, etc.
- Follow procedures and documentation of study payment.
- Assist with management of Investigational Products (IP) including arrival, storage, handling including requesting requisitions, inventory, and reordering.
- 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.
- 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.
Study and Site Management:
- 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
Conduct literature reviews under the direction of the CRC, CRNC, or PI.
- Assist with development of research proposals or protocols.
- 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. 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
- Use required processes, policies, and systems to ensure data security and provenance. Recognize and report vulnerabilities related to security of physical and electronic data. Assist in investigating incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data. Follow SOPs for data QA.
- 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.
- Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research.
- Make recommendations to investigative team.
- 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 %):
- Tissue and Data Acquisition Network: 50%
- Endometrial Cancer Database: 10%
- Immuneprofile of Gynecologic Malignancies: 10%
- Preference Elicitation Studies: 10%
- Division Supported Projects: 10%
- Trainee Projects: 10%
Type of Research
Will be involved with non-interventional GYN ONC research. Will work under the direction of a Clinical Research Coordinator.
Requisition Number 401499980
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/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, interactionwith study population, program coordination).
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