CLINICAL RESEARCH NURSE COORDINATOR, SR
CLINICAL RESEARCH NURSE COORDINATOR, SR
Provide oversight and training to entire unit or department with regards to subject screening. Set up unit-wide systems, policies related to subject screening. Provide oversight and training to entire unit or department with regards to maintaining subject level documentation. Set up unit-wide systems, policies related to subject level documentation. May conduct study visits independently. Serve as a unit/departmental resource and train others regarding preparation and conduct of study visits, creation of SOPs, and implementation of operational plans. Create, optimize, and oversee systems to collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks. Design best methods for management of IP. Oversee implementation of and compliance with the required system for handling, dispensing and documentation of IP for sponsored protocols. Serve as an expert resource for study teams, DUHS procurement, billing and compliance for the proper handling of Investigational Product (IP). Participate in or lead development of policies and guidances related to study level documentation. Participate in or lead development of policies and guidances related to subject recruitment. Serve as an expert resource across unit or department. Participate in or lead development of policies and guidances related to consent. Serve as an expert resource across unit or department. Participate in or lead development of policies and guidances related to monitoring and audits. Serve as an expert resource when addressing and correcting findings. Oversee the collection of adverse event information for an entire unit or department Provide input for AE reports. Serve as a resource to junior staff as well as the unit, department, or division staff with regard to institution and sponsor-specific prompt reporting requirements (timelines and forms). Liaise with contact for final determination of safety event outcome. Possess thorough understanding of intellectual property rights, inventions, patents, and technologies. Coordinate with Duke core services such as Investigational Drug Service, Biobank, etc. Coordinate necessary agreements (e.g., Material Transfer Agreements, Investigational New Drug Applications, etc.). Serve as a unit, department, or division resource for development of IRB documents and for guidance on IRB communications
Serve as a resource to unit or department to help staff and patients recognize the difference between clinical care and clinical management of research participants Assist in the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations. Assist others with application of these principles. 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.
Map protocol data flow and predict areas of vulnerability. Determine solutions for vulnerabilities for data flow plans for multiple studies. Use EDC systems and enter data accurately and train others in these tasks. Detect issues related to data capture, collection or management and suggest solutions. Use required processes, policies, and systems to ensure data security and provenance. Recognize and report vulnerabilities related to security of physical and electronic data. Develop and follow SOPs for data QA. Monitor QA of study data. Assemble the necessary parties to ensure that all agreements are in place (DUA, DTA, etc.)
Conduct literature reviews independently
Actively network and encourage leadership for staff within a small work group. Take part in a committee, task force, or ad hoc group. Encourage career development by actively seeking out continuing education opportunities for self and study team members. Participate in scientific presentations and publications. Serve as expert mentor to junior staff. Establish and assign the activities of multiple teams to accomplish study goals. Serve as a unit-wide expert resource for issues related to professional guidelines and code of ethics. Maintain training requirements and develop solutions to proactively ensure unit, department, division's compliance with training requirements. Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research. Make recommendations to investigative team.
Study and Site Management:
Determine and implement alternative solutions to accomplishing recruitment and retention milestones. Provide expert guidance to study team members to ensure participant care expenses have been set up correctly and that financial charges/expenses route in a timely manner; troubleshoot, escalate, and resolve issues. Collaborate with the financial analyst to establish financial monitoring systems. Determine when financial reports are not working as planned and collaborate with sponsor and financial managers to troubleshoot. Develop study budgets. Provide leadership/training to entire unit/department with regard to compliance with institutional requirements and other policies Work with sponsors and study teams to arrange required sponsor training. Provide feedback to the study team members; and serve as an institutional resource to the study visitors Develop and implement closeout procedures for multiple studies, unit, department, or division.
Act as an expert resource to junior staff liaising with sponsors, subcontractors, or vendors. Responsible for items listed above, and in addition, recognize when team member communication is not going well and troubleshoot the issue.
Description of Portfolio and Clinical Responsibilities:
Portfolio Management :
- Adult Medication, , , , Peripheral IV Insertion and Maintenance
Type of Research
Lead CRNC for the pulmonary division. This individual will be responsible for coordinating studies anywhere within the division. This encompasses 10 pulmonary clusters aiding critical disease populations and managing complex studies. Study procedures vary from pulmonary function diagnostic testing to bronchoscopies. This position will lead, manage, and mentor junior staff.
1204 CLINICAL RESEARCH NURSE COORDINATOR, SR
Job Family Level
Full Time / Part Time
Regular / Temporary
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.
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 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.
Respiratory therapy helpful but not required.
Auto req ID
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.