CLINICAL RESEARCH NURSE COORDINATOR


diversity employer



CLINICAL RESEARCH NURSE COORDINATOR
Phase 1 Clinical Research

Occupational Summary

Participate in clinical research studies conducted by principal investigators (PIs) for the Duke Cancer Institute's (DCI) Oncology Clinical Research Unit (OncCRU) for the Phase I Team. Perform a variety of duties related to the implementation of clinical research protocols, including but not limited to, collection, compilation, documentation, & analysis of clinical research data; and/or the coordination of the research study.

Work Preformed

Clinical Research Operations- Screen, schedule, consent, & collect adverse event 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 & document visits and protocol- specific testing/interviews according to study protocol, operational plans of clinical departments, and Standard Operating Procedures (SOPs) for all types of studies independently. Employ strategies to maintain recruitment & retention rates, & to assist participants with individual needs.
Evaluate processes to identify issues related to recruitment & retention rates.

Develop or provide input for Institutional Review Board documents such as consent forms, protocols, & continuing reviews in a timely fashion. Maintain or collaborate to maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc.

Collect, prepare, or process adverse event information per protocol, & provide input for adverse event reports.

May complete & submit Adverse Events Reports, according to institution & sponsor-specific prompt reporting requirements (timelines & forms).

Ethical & Participant Safety Considerations- Maintain familiarity with the ethical conduct of research & safeguards needed when conducting research with vulnerable populations. Understand that the safety of research participants is a priority. Train junior staff in the ethical conduct of research, dealing with vulnerable populations, & provide guidance in strategies used to maintain safety. May help in the design of studies so they include specific safeguards to ensure ethical conduct & protect vulnerable populations.

Communicate to research participants, both orally & written, the difference between clinical activities & research activities, & the risks & benefits of study participation, in all study documents & research participant communications.

Data Management & Informatics- Use & train others in Electronic Data Capture (EDC) systems, technologies, & software necessary for study operations. 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. Assist with the development of data collection documents to standardize process. Detect issues related to data capture, collection or management; suggest solutions. May independently design ECRFs and EDCs to collect data and select methods of data capture and discuss advantages and disadvantages of each.

Investigate incomplete, inaccurate, or missing data or documents to ensure accuracy & completeness of data; follow and develop, or assist with development of, SOPs for data quality assurance. Adhere to processes and run queries, summaries, & reports to monitor the quality of data.

Use required processes, policies, & systems to ensure data security & data provenance. Recognize & report vulnerabilities related to security of physical & electronic data; suggest & implement solutions to vulnerabilities related to security of data & data provenance.

Map protocol data flow & predict areas of vulnerability. Determine areas where data provenance may be compromised.

Recognize when data agreements or special regulatory requirements are necessary; may assemble the necessary parties to ensure that all agreements are in place (e.g., data use agreements, data transfer agreements, Investigational Device Exemptions (IDEs), etc.).

Scientific Concepts & Research Design- Understand and train others in the basic concepts of study design. Independently conduct literature reviews. Assist with the development of or develop proposals or protocols; identify shortcomings of proposals and protocols.

Leadership & Professionalism- Encourage and support colleagues to complete project work. Assist research colleagues in identifying efficiencies and improving process. Actively network and encourage leadership for staff within a small work group. Successfully take part in or lead a committee, task force, or ad hoc group. Encourage career development by actively seek out continuing education opportunities for self and study team members. Participate in or lead scientific presentations and publications.

Assign, review, and train others in various work responsibilities. Serve as a mentor to junior staff, including other Clinical Research Coordinators. 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, the professional guidelines and code of ethics related to the conduct of clinical research.

Study & Site Management- Participate in sponsor-required training. Obtain information for or coordinate operational plans for multiple research studies. Develop protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms.

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. Assist with study budgets.

Prepare for, take part in, and potentially lead site initiation, monitoring, and closeout visits and document storage activities.

Collect information to determine feasibility, recruitment and retention strategies.

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.

Communication & Team Science- Prepare for and lead team meetings. Recognize when others need to be brought into the conversation and escalate appropriately. Expand on the ideas of peers or team members.
Other work as assigned.

The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.


Requisition Number
401294542

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, 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.

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 experience is required.

Preferences:

Experience in Oncology, ICU and/or Research

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


Auto req ID

92044BR

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.

PI98744296