CLINICAL RESEARCH COORDINATOR - PEDS
CLINICAL RESEARCH COORDINATOR - PEDS
Pediatrics-Pulmonary and Sleep Med
- Screen participants for all studies independently. Maintain subject level documentation for all studies independently
- Schedule participants and conduct visits for all studies independently.
- Train others to conduct and document visits and protocol-specific testing/interviews.
- Assist with development and follow procedures and documentation of study payment in timely fashion.
- Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks.
- Independently 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 a variety of studies independently
- Assist with addressing and correcting findings from study monitoring and study audit visits.
- Collect, prepare or process adverse event information independently Complete and submit AE Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) independently.
- Develop DUHS IRB documents such as consent forms, protocols, and continuing reviews independently.
- Recognize when patients are having difficulties with this distinction. Make recommendations regarding how to improve communications to help patients and staff understand the distinction. 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 Data: Map a protocol's data flow plan: data capture, storage, management, quality, and preparation for analysis
- 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.
- Recognize and report vulnerabilities related to security of physical and electronic data. Independently investigate incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data.
- Run summaries and reports on existing 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.
Study and Site Management:
- 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., 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 and closeout meetings independently
- 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
- 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 (Clinical responsibilities: • Other: Type of Research Pediatric Phase II/III/IV, data repository & specimen repository. Independently plan and implement the day-to-day activities associated with multiple research projects within the Division of Pediatric Allergy, Immunology & Pulmonology's AIP Translational research Program (ATP). Special Skills Candidate must have CRC experience in and be comfortable working with pediatric patients and their families. Candidate required to have good communication skills with colleagues, be resourceful and be organized and composed in a research environment.
1201 CLINICAL RESEARCH COORDINATOR
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.
1.Completion of a Bachelor's degree 2.Completion of an Associates degree plus a minimum of two years relevant experience (e.g., research, clinical, interaction with study population, program coordination)
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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.