CLINICAL RESEARCH NURSE COORDINATOR, SR


diversity employer



CLINICAL RESEARCH NURSE COORDINATOR, SR
Duke Office of Clinical Research

Occupational Summary

Lead day-to-day operations of clinical research studies conducted by principal investigator(s) at Duke Medicine perform a variety of complex duties involved in the collection, compilation, documentation, and analysis of clinical research data lead others through navigating the clinical research environment. Lead or participate in a variety of DOCR led initiatives. Oversee the work of Clinical Research Coordinators and other research staff as requested. This position will report to the Assistant Research Program Manager-RN in the Duke Office of Clinical Research.

Work Performed

1. Clinical research operations. Provide oversight and training to team members who screen, schedule, consent, and collect adverse event information for participants in a variety of studies. Provide oversight and training to team members who maintain subject level documentation, including documentation in the electronic medical record. Serve as a resource and train others regarding preparation and conduct of study visits, creation of SOPs, and implementation of operational plans. Evaluate processes to identify issues related to recruitment and retention, and implement innovative solutions to maximize recruitment and retention.

Develop IRB documents and train other staff in these tasks. Train staff to maintain exemplary documentation, including regulatory binders, enrollment logs, patient registration in the system of record, subject level documentation, etc.

Design best methods for management of IP for drug, device, and biologic studies. Oversee implementation of, and compliance with, the required systems for IP for sponsored protocols. Serve as an expert resource for study teams, DUHS procurement, billing, and compliance for the proper handling of IP. Coordinate with Duke core services such as Investigational Drug Service, Biobank, etc.

Direct study teams compliance with appropriate collection of AE information per protocol, and provide input for adverse event reports. Serve as a resource to junior staff and the department or division with regard to institution and sponsor specific reporting requirements.

2. Ethical and participant safety considerations. Provide division or department wide
training in ethical conduct of research, and provide guidance in strategies used to maintain safety. Serve as expert resource to study teams as they design studies, so they include specific safeguards to ensure ethical conduct and protect vulnerable populations. Articulate, to study staff and research participants, the pathophysiology or reasoning for an individual protocol's inclusion and exclusion criteria.

Serve as a resource to help staff and patients recognize the difference between clinical care and clinical management of research participants.

Independently develop documents related to safety and security. Serve as an expert resource for development and implementation of RDSPs, DSMPs, and Conflict of Interest plans across multiple studies or study teams.

3. Data management and informatics. Use and train others in Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations. Independently design CRFs to collect data according to protocol. Select methods of data capture and discuss advantages and disadvantages of each.

Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data. Oversee the creation and use of queries, summaries, and reports. Develop system/framework for QA processes for multiple studies.

Develop quality assurance systems for research data ensure that QA SOPs are updated and followed by study teams. Implement quality assurance systems across multiple studies, or across entire unit, department or division.

Map protocol data flow and predict areas of vulnerability. Determine solutions for vulnerabilities in data flow plans for multiple studies. May implement at unit level.

4. Scientific concepts and research design. Train others in the basic concepts of study design. Conduct and synthesize literature reviews, and independently develop proposals or protocols.
Summarize and interpret study results, and determine application to future study procedures.

5. Leadership and professionalism. Assist research colleagues in identifying efficiencies and improving process. May provide significant contribution and influence upon research work, activities, or productivity of project teams or across multiple groups.
Serve as a resource for issues related to professional guidelines and code of ethics. Identify potential problems and risks to the participant, study, and institution.

Maintain Duke and project specific training requirements. Develop solutions to proactively ensure unit, department, or division compliance with training requirements.

6. Study and site management. Provide expert guidance to study team members to ensure participant care expenses have been set up correctly and that financial charges/expensed route in a timely manner troubleshoot, escalate, and resolve issues. Collaborate with the financial analyst to establish financial monitoring systems. Coordinate with financial teams, PRMO, etc. Determine when financial reports are not working as planned and collaborate with sponsor and financial managers to troubleshoot. Develop study budgets.

Coordinate operational plans for multiple research studies. Develop systems and documents including process flows, training manuals, and SOPs as appropriate with study teams.

Work with sponsors/study teams to arrange required training. Lead site initiation, monitoring, and closeout visits and activities provide feedback to the study team members. Develop and implement closeout procedures for multiple studies.

Use system reports to ensure compliance with institutional requirements and other policies assist team members with understanding these requirements and policies. Oversee maintenance of Delegation of Authority Logs and training of KP on study specific duties.

7. Communication and team science. Act as an expert resource to junior staff liaising with sponsors, subcontractors, or vendors. 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. Take an active role in including others in decision-making.

8. Nursing activities. Plan, provide, supervise and document professional research nursing activities utilizing the nursing process for research subjects in accordance with physician orders and established policies and procedures. Use professional nursing judgment when conducting nursing research activities to patients.

Appropriately order sets following institutional and protocol guidelines.

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.

Complete 18 hours of Continuing Education per year. Maintain compliance with required hospital and unit specific training competencies.



Requisition Number
401282450

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1204 CLINICAL RESEARCH NURSE COORDINATOR, SR

Job Family Level
55

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, plus four years of research experience. For those with an associate's degree, a minimum of six years of research experience is required.

Auto req ID

91319BR

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.

PI98815052