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CLINICAL RESEARCH NURSE COORDINATOR

Job description


diversity employer



CLINICAL RESEARCH NURSE COORDINATOR
Medicine - Gastroenterology

Occupational Summary
Participate in clinical research studies conducted by Gastroenterology principal investigator(s); serve as RN for research liver biopsies; perform indwelling catheter PK blood draws; perform a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data.
Work Performed
1.Clinical research operations. Screen, schedule, consent, and collect adverse events information for participants in a variety of studies. Maintain subject level documentation, including documentation of consent in the electronic medical record. Prepare documents, equipment, or supplies for research visits. Conduct and document visits and protocol-specific testing independently. Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs.
Collect, prepare, process, ship, and maintain inventory of research specimens
Prepare for study monitoring or study audit visits; correct findings.
Develop or provide input for IRB documents. Maintain, or collaborate to maintain, appropriate study-level documentation.
Manage Investigational Products (IP). Employ the required system for handling, dispensing and documentation of IP for sponsored protocols.
Have familiarity with intellectual property rights, inventions patents, and technologies. As appropriate, understand regulations related to investigational products with sponsors.
2.Ethical and participant safety considerations. Maintain familiarity with the ethical conduct of research and safeguards needed when conducting research. Train junior staff in the ethical conduct of research.
Communicate to research participants the difference between clinical activities and research activities, and the risks and benefits of study participation.
3.Data management and informatics. Use and train others in Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations. Complete Case Report Forms accurately according to protocol. Develop and implement data collection documents and instruments. Detect issues related to data capture, collection or management; suggest solutions.
Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data; develop and implement SOPs for data quality assurance. Recognize trends related to data quality and escalating as appropriate.
Use required processes, policies, and systems to ensure data security and data provenance. 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.
Determine areas where data provenance may be compromised and develop solutions.
Recognize when data agreements or special regulatory requirements are necessary; may assemble the necessary parties to ensure that all agreements are in place.
4.Scientific concepts and research design. Understand and train others in the basic concepts of study design. Independently conduct literature reviews.
Identify various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of study aims.
5.Leadership and professionalism. Assist research colleagues in identifying efficiencies and improving process. Successfully take part in or lead a committee or task force. Actively seek out continuing education opportunities for self and study team members.
Assign, review, and train others in various work responsibilities. Serve as a mentor to junior staff, including other CRCs. Employ escalation and performance plans as needed.
Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research; summarize and clarify for study teams. Identify potential problems and risks to the participants, study, and institution and offer constructive resolution.
6.Study and site management. Participate in and operationalize sponsor-required training for multiple research studies. Develop protocol-specific systems and documents including process flows, training manuals, SOPs, and CRFs.
Ensure participant care expenses have appropriate financial routing. Monitor financial study milestones and report appropriately.
Lead site initiation, monitoring, closeout visits, and document storage activities. Collect information to determine feasibility, recruitment and retention strategies.
Maintain compliance with institutional requirements and policies. Oversee maintenance of Delegation of Authority Logs and training of KP on study specific duties.
7.Communication and team science. Take an active role in including others in decision-making, and escalate issues appropriately.
Communicate with sponsors, subcontractors, or vendors. May be responsible for taking action when communication has stalled with sites, CROs, sponsors.
Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research. Make recommendations to investigative team.
8.Nursing activities. Plan, provide, supervise, and document professional nursing care utilizing the nursing process for patients in accordance with physician orders and established policies and procedures. Use professional nursing judgment when conducting nursing research activities to patients.
Delegate tasks and supervise the activities of other licensed and unlicensed research staff.
Monitor and initiate corrective action to maintain the environment of care, including equipment and material resources. Participate in the identification of clinical or operational performance improvement opportunities and in performance improvement activities.
Maintain compliance with required hospital and unit specific training competencies.



Requisition Number
401439207

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:

Clinical Research Coordinator experience preferred. ACRP or SOCRA certification preferred.

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


Auto req ID

101877BR

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: 6/14/2018
Application Due: 7/2/2018
Work Type:
Salary: