Clinical Research Nurse Coordinator
The Marcus Center for Cellular Cures has an exciting opportunity for a Clinical Research Nurse Coordinator located in Durham, N.C. More information about the Marcus Center is located at the following link:
Preferred skills include: background in research, including consenting, coordinating study visits, experience in working with interdisciplinary teams, pediatrics and IV skills.
Clinical research operations:
- Screen, schedule, consent, and 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 and 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 and retention rates, and to assist participants with individual needs.
- Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks; improve systems related to specimen handling. Prepare for study monitoring or study audit visits. Assist with addressing and correcting findings. Develop or provide input for Institutional Review Board documents such as consent forms, protocols, and 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.
- Assist with management of Investigational Products (IP) including arrival, storage, handling, requesting requisitions, inventory, reordering, drug accountability, reconciliation, and destruction.
- Maintain appropriate documentation. Track IP compliance at the protocol-and subject level. Collect, prepare, or process adverse event information per protocol, and provide input for adverse event reports. May complete and submit Adverse Events Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms).
- 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.).
Ethical and participant safety considerations:
Maintain familiarity 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. May help in the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations. Coordinate or assist with the coordination of efforts of external monitoring boards. Communicate to research participants, both orally and written, the difference between clinical activities and research activities, and the risks and benefits of study participation, in all study documents and research participant communications. May recognize when patients are having difficulties with this distinction. May make recommendations regarding how to improve communications to help patients and staff understand the distinction.
Data management and informatics:
Use Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations. Enter data accurately, 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.
Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data; follow and develop, or assist with development of, SOPs for data quality assurance. Adhere to processes and run queries, summaries, and reports to monitor the quality of data. May develop QA processes and oversee the creation and use of queries, summaries, and reports for quality assurance purposes. May be responsible for recognizing 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.
Map protocol data flow and predict areas of vulnerability. Determine areas where data provenance may be compromised. May be responsible for determining solutions to vulnerabilities related to security of data and data provenance.
Leadership and 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. May be responsible for providing constructive feedback to team members.
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. May be responsible for identifying potential problems and risks to the participant, study, investigator, team, sponsor, and institution.
Study and 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. Coordinate with financial teams, PRMO, etc. 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. May make recommendations to investigators and oversight organization(s). 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.
Requisition Number: 401508894
Duke Entity: MEDICAL CENTER
Job Code: 1203 CLINICAL RESEARCH NURSE COORDINATOR
Job Family Level: 54
Full Time/Part Time: FULL TIME
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.
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.
Twelve months of appropriate clinical nursing experience is required.
Auto req: ID106068BR