Duke University CLINICAL RESEARCH SPECIALIST, SR - DEPT OF ORTHOPAEDICS in Durham, North Carolina
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803 CLINICAL RESEARCH SPECIALIST, SR
Perform a variety of research, data, and clerical duties of a routine and technical nature to support the conduct of clinical research under the supervision of a Clinical Research Coordinator or similar CRU/Oversight Organization designee. Participate in day-to-day operations related to the collection, compilation, and documentation of clinical research data.
Operations: Identify participants that meet eligibility requirements under the supervision of a CRC/CRNC. Document in record. Maintain subject level documentation for all studies independently 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. 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. Evaluate processes to identify issues related to recruitment andretention 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 independently. Provide input for adverse event reports Provide input for DUHS IRB documents such as consent forms, protocols, and continuing reviews.
Ethics: 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 SafetyMonitoring 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
Data: Map a protocol's data flow plan: data capture, storage, management,quality, and preparation foranalysis 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
Science: Summarize study results
Leadership: Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research. Make recommendations to investigative team.
Study and Site Management: Collect information to determine appropriate feasibility, recruitmentand retention strategies.Ensure participant care expenses have appropriate financial routing in a timely manner. Monitor financial study milestones and report appropriately. Coordinate with financial teams, PRMO, etc.and participate in budget development as appropriate. Assist with study budgets. Maintain study's compliance with institutional requirements and other policies (e.g., NIHPublic 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 insite 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. Take part in or lead closeout and document storage activities
Communication: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.
CLINICAL RESEARCH SPECIALIST, SR - DEPT OF ORTHOPAEDICS
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Duke University is an Affirmative Action/Equal Opportunity Employercommitted to providing employment opportunity without regard to anindividual's age, color, disability, gender, gender expression, genderidentity, 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 robustexchange of ideas—an exchange that is best when the rich diversity ofour perspectives, backgrounds, and experiences flourishes. To achievethis exchange, it is essential that all members of the community feelsecure and welcome, that the contributions of all individuals arerespected, and that all voices are heard. All members of our communityhave a responsibility to uphold these values.
Essential Physical Job Functions:Certain jobs at Duke University and Duke University Health System mayinclude essential job functions that require specific physical and/ormental abilities. Additional information and provision for requests forreasonable 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).