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CLINICAL RESEARCH NURSE COORDINATOR

Job description


diversity employer



CLINICAL RESEARCH NURSE COORDINATOR
Coop Clinical Rsch

This is a 100% sponsored funded position.

Occupational Summary
Develop, coordinate, and supervise research and administrative activities of clinical research studies conducted by principal investigators (PIs) for the National Clinical Trials Network Clinical Research Program (NCTN) and associated programs as the NCTN Scope expands; develop and oversee a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data and specimen submission.
You will build and maintain a close, collaborative working relationship with the NCTN CRP, associated program personnel, and disease group study teams, including: PIs, investigators, nurses, data and regulatory coordinators, and other clinical research staff to effectively manage research studies within the NCTN with the Duke Cancer Institute (DCI) & Oncology Clinical Research Unit (OncCRU) administrative team and the oncology department staff.

Work Preformed

Clinical Research Operations-
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. Assist with management of IP. Employ the required system for handling, dispensing and documentation of IP for sponsored protocols. Track IP compliance at the protocol-and subject level. 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. Conduct and document consent for participants in a variety of studies independently and provide training to others in these tasks. 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. Have familiarity with intellectual property rights, inventions patents, and technologies. As appropriate, understand regulations related to investigational products with sponsors. Coordinate with Duke core services such as Investigational Drug Service (IDS), Biobank, etc. Recognize the need for agreements (e.g., Material Transfer Agreements, Investigational New Drug Applications, etc.). Provide input for DUHS IRB documents such as consent forms, protocols, and continuing reviews.
Ethics
Recognize when patients are having difficulties with this distinction. 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. Articulate, to study staff and research participants, the pathophysiology or reasoning for an individual protocol's inclusion and exclusion criteria.
Data Management
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. Recognize and report vulnerabilities related to security of physical and electronic data. Suggest and implement solutions to vulnerabilities related to security of data and data 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
Leadership
Encourage and support colleagues in completing project work. Assist research colleagues in identifying efficiencies and improving process. Lead study teams with regard to clinical research professional guidelines and code of ethics. Identify potential problems and risks to the participant, study, investigator, team, sponsor, and institution. Maintain Duke and project specific training requirements. Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research.
Study & 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. 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. Take part in or lead closeout and document storage activities.
Communication
Take action when communication has stalled with sites, CROs, sponsors. 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.
And other work as assigned.
Perform other related duties incidental to the work described herein. The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
The intent of this job description is to be representative of the level and the types of duties and responsibilities that will be required of this position and shall not be construed as a declaration of the total specific duties and responsibilities.

Requisition Number
401416411

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1203 CLINICAL RESEARCH NURSE COORDINATOR

Job Family Level
54

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

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.

Preferences
Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).


Auto req ID

100367BR

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.

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Job No:
Posted: 5/13/2018
Application Due: 5/23/2018
Work Type:
Salary: