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CLINICAL RESEARCH NURSE COORDINATOR - PEDS/MEDICAL GENETICS

at Duke University Hospital

Posted: 9/17/2019
Job Reference #: 1362059
Keywords: clerical

Job Description

Auto req ID
112149BR

Duke Entity
MEDICAL CENTER

Job Code
1203 CLINICAL RESEARCH NURSE COORDINATOR

Job Description
Participate in a variety of research, data base, and clerical duties of a complex and technical nature for clinical trials and clinical research within Pediatric Medical Genetics Division involving studies with adult and children with rare metabolic diseases and genetic disorders.

Operations: Screen participants for all studies independently. May maintain subject level documentation for all studies independently. Provide oversight and training to study team members who maintain subject level documentation, including documentation in the EMR. 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. Evaluate processes to identify issues related to recruitment and retention rates. Independently conducts and documents consent for participants in all studies, including those that are complex in nature/clinically relevant and/or require access to the EHR for documentation. May train or oversee others. Provide direction to study teams with preparation for study monitoring or study audit visits. Address and correct audit/monitor findings. 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.

Ethics: 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: Use EDC systems and enter data accurately and train others in these tasks. Detect issues related to data capture, collection or management and suggest solutions. 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 issues related to accuracy and completeness of data. Develop and run queries and reports. Recognize trends related to data quality and escalate as appropriate. Follow SOPs for data QA.

Science: Conduct literature reviews independently Summarize study results. Leadership: 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. 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. Prepare items for site initiation visits. Participate in sponsor required training Prepare for closeout and document storage.

Communication: Serve as primary liaison with single sponsor, subcontractor, or vendors. Communicate concerns clearly and in a professional manner. 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 responsibilities: • Ambulatory Medication Administration • Adult Medication • Pediatric Medication • Peripheral IV Insertion and Maintenance • Alaris Pump Set up and Use • Other: Varies depending on need of particular project Special Skills Candidate must be organized with strong regulatory experience, ability to conduct research study visits and assessments independently utilizing GCP in all study activities.

Location
Durham

Requisition Number
401581994

Position Title
CLINICAL RESEARCH NURSE COORDINATOR - PEDS/MEDICAL GENETICS

Shift
First/Day

Job Family Level
54

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Department Name
Pediatrics-Medical Genetics

Minimum Qualifications
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.

Education

Work requires graduation from an accredited BSN or Associate's Degree in Nursing or Nursing Diploma program. All registered nurses without a Bachelor's degree in Nursing (or higher) will be required to enroll in an appropriate BSN program within two years of their start date and to complete the program within five years of their start date. Must have current or compact RN licensure in the state of North Carolina. BLS required.

Experience

Twelve months of appropriate clinical nursing experience is required.