Clinical Research Nurse Coordinator Sr

4 weeks ago

Durham, United States Duke University Full time
School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Occupational Summary

Provide leadership for a clinical team that conducts multiple, complex oncology clinical trials and research studies including Investigational Products [IP] for the Duke Cancer Institute's [DCI] Breast Clinical Research Program [BRST]. The Oncology Clinical Research Unit [CRU] oversees the conduct of research.

Work Preformed

Operations, Study and Site Management - 20% Effort
  • Employ strategies to maintain recruitment and retention rates, and assist participants with individual needs. Oversee the collection of information used to evaluate study feasibility, recruitment and retention strategies. Evaluate processes to identify issues related to recruitment and retention rates; design solutions.
  • Work closely with the Principal Investigator [PI] and study team on recruitment and enrollment of study participants. Conduct and document consent for study participants.
  • Coordinate study activities for direct reports to successfully implement and conduct the study. Recognize and offer solutions to study problems. Escalate issues appropriately. Assist in the development of new studies. Oversee site initiation and closeout visits.
  • Oversee study compliance with institutional requirements, policies and appropriate study-level documentation such as regulatory binders, enrollment logs, and patient registration in the system of record. Ensure adverse events [AE] are recorded and reported appropriately. Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties.
  • Lead the development of Conflict of Interest [COI], Data Safety Monitoring Plans [DSMPs], and Research Data Security Plans [RDSPs]. Lead the coordination of external monitoring boards.
  • Oversee the procedures and documentation of study payment and participant care expenses. Monitor financial study milestones and report appropriately. Coordinate with financial teams and participate in budget development. Lead study budgets and closeouts.
Communication - 20% Effort

Serve as an expert resource on the conduct of research. Collaborate, and communicate with study personnel as required. Communicate concerns clearly in a professional manner. Respond timely to emails, phone calls and questions. Escalate issues to others as appropriate.

Data - 10% Effort
  • Detect issues related to data capture, collection or management and suggest solutions.
  • Oversee the required processes, policies, and systems to ensure data security and provenance. Recognize and report vulnerabilities related to security of physical and electronic data. Review data entry for accuracy and completeness; offer solutions to correct incomplete, inaccurate or missing data and documents to ensure accuracy and completeness of data.
Leadership - 25% Effort
  • Create a team culture that fosters open communication, motivates staff, and encourages creativity. Oversee the fair and consistent application of human resource policies. Collaborate closely with DCI Human Resources on personnel issues; policies, personnel file documentation and compliance.
  • Lead, supervise and manage assigned staff - their day-to-day assignments, work schedule, work location, approve time off requests, conduct yearly evaluations, and actively engage in performance management including coaching, career development, training and corrective action. Establish regular communication methods and meetings with staff; collectively and individually. Be available to staff on a routine basis to provide leadership and mentoring.
  • Provide staff with clear measurable goals, monitor performance and quality of work. Assign staff duties and responsibilities; cross-train and reassign as needed. Foster and encourage the professional development of staff. Oversee staff training and certifications to ensure compliance with standard operating procedures [SOPs], regulations and processes.
  • Serve as an expert resource for colleagues and teammates. Support colleagues in their project work; encourage completion.
Ethics - 10 % Effort
  • Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research.
  • Know and follow policies, standard operating procedures [SOPs], regulations and protocol requirements that govern clinical research. Maintain Duke and project specific training and certification requirements.


RN Responsibilities - 15% Effort

Operate within the scope of the professional capacity of a licensed RN as it relates to research. Provide direction and training to RN staff as needed.

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.

Minimum Requirements

Education

Work requires graduation from an accredited BSN or Associates Degree in Nursing or Nursing Diploma program. All registered nurses without a Bachelors degree in Nursing (or higher) are encouraged to enroll in an appropriate BSN program within two years of their start date but must complete the program within seven years of their start date. Must have current or compact RN licensure in the state of North Carolina. BLS required. Maintain compliance with required hospital and unit specific training competencies as well as an active RN status with the North Carolina Board of Nursing (NCBON). Exception: Registered nurses hired before September 1, 2016 are not required to enroll in a BSN program to remain in this job classification.

Experience

Twelve months of appropriate clinical experience is required, plus four years of research experience.

Preferences

Previous oncology or research experience is preferred

Job Code: 00001204 CLINICAL RESEARCH NURSE COORDINATOR, SR
Job Level: 55

Duke 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.

  • Senior Clinical Research Nurse Coordinator

    2 weeks ago

    Durham, North Carolina, United States Duke University Full time

    About Duke University School of Medicine Duke University School of Medicine, established in 1930, is recognized as one of the premier medical schools in the United States, currently ranked sixth nationally. The institution prides itself on fostering an inclusive environment that encourages collaboration among exceptional learners, researchers, clinicians,...

  • Senior Clinical Research Nurse Coordinator

    2 weeks ago

    Durham, North Carolina, United States Duke University Full time

    About Duke University School of Medicine Duke University School of Medicine, established in 1930, is recognized as one of the leading medical schools in the United States, ranking sixth nationally. Our institution prides itself on fostering an inclusive environment for exceptional learners, researchers, clinicians, and staff, promoting interdisciplinary...

  • Clinical Research Coordinator I

    5 days ago

    Durham, North Carolina, United States Durham - Clinical Site Full time

    About Durham - Clinical SiteDurham - Clinical Site is a leading research organization dedicated to delivering high-quality clinical trials and exceptional patient care. Our team of experts is committed to advancing medical research and improving patient outcomes.Job SummaryWe are seeking a highly skilled Clinical Research Coordinator I to join our team. The...

  • Clinical Research Coordinator, Duke Cancer Institute

    5 days ago

    Durham, North Carolina, United States Duke Health Full time

    Job SummaryWe are seeking a highly skilled Clinical Research Coordinator to join our team at Duke Health. The successful candidate will be responsible for providing leadership and coordination in the conduct of multiple, complex oncology clinical trials and research studies.Key ResponsibilitiesProvide leadership and coordination in the conduct of multiple,...

  • Senior Oncology Research Nurse Coordinator

    2 weeks ago

    Durham, North Carolina, United States Duke University Full time

    Institution Overview Duke University School of Medicine, established in 1930, is recognized as one of the premier medical schools in the United States, ranking sixth nationally. The institution prides itself on fostering an inclusive environment for exceptional learners, researchers, clinicians, and staff, promoting interdisciplinary collaboration to...

  • Clinical Research Coordinator, Duke Cancer Institute

    3 months ago

    Durham, United States Duke Health Full time

    Clinical Research Coordinator, Duke Cancer Institute Work Arrangement: Requisition Number: 245160 Regular or Temporary: Regular Location: Durham, NC, US, 27710 Personnel Area: MEDICAL CENTER Date: Jun 30, 2024 School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth...

  • Associate Director, Clinical Research

    3 months ago

    Durham, United States SHATTUCK LABS, INC. Full time

    Job DescriptionJob DescriptionAbout the position: The Associate Director/Director of Clinical Research, in collaboration with the Medical Monitor, is responsible for the design, conduct, analysis, and reporting of clinical trials. This individual will assume a lead role in trial planning and execution, working with a multi-disciplinary team to ensure...

  • Registered Nurse Case Management

    1 day ago

    Durham, United States Clinical Management Consultants Full time

    An award winning health system is seeking an experienced Registered Nurse Case Manager to join their team! This award winning academic medical center is a leading healthcare provider in North Carolina, offering cutting-edge treatments and patient-centered care. It is affiliated with a top-tier public university and is known for its excellence in research,...

  • Genetic Counselor

    2 days ago

    Durham, North Carolina, United States Duke University Full time

    Job SummaryWe are seeking a highly skilled Clinical Research Genetic Counselor to join our team at Duke University. The successful candidate will be responsible for participating in or leading day-to-day operations of clinical research studies conducted by Principal Investigators within the Medical Genetics division.Key ResponsibilitiesScreen, schedule,...

  • Director of Research and Clinical Services

    3 days ago

    Durham, North Carolina, United States Duke Health Full time

    About the RoleThe Duke Department of Pediatrics at Duke University Medical Center is seeking a highly qualified Director of Research and Clinical Services to join our team. As a key member of our department, you will be responsible for advancing our research agenda and providing clinical services in the Duke University Hospital Emergency Department.Key...

  • Research Compliance Coordinator

    3 weeks ago

    Durham, United States North Carolina Central University Full time

    Working Title Research Compliance CoordinatorPosition Number 717462Appointment Type Permanent - Full TimeTenure Track NoFTE 1 = 40 hours/week, 12 monthsIf time limited, duration datePosition OverviewPrimary Function of Organizational UnitThe Office of Research Compliance and Technology Transfer plays a critical role in supporting and strengthening a culture...

  • Clinical Research Lead

    2 weeks ago

    Durham, North Carolina, United States Indotronix Avani Group Full time

    Position Overview:The Clinical Research Scientist plays a pivotal role in overseeing the integrity and accuracy of data within preclinical studies. This position is essential for ensuring compliance with Good Laboratory Practice (GLP) standards and facilitating high-quality research outcomes.Key Responsibilities:Serve as the Primary Data Reviewer for...

  • Research Administration Coordinator

    7 days ago

    Durham, North Carolina, United States Duke University Full time

    About the RoleDuke University, a world-renowned research institution, seeks a highly skilled Grants and Contracts Specialist to join its team. As a key member of the department, you will play a critical role in supporting the development, submission, and management of grants and contracts.Job SummaryThe Grants and Contracts Specialist will be responsible for...

  • Research Operations Specialist

    5 days ago

    Durham, North Carolina, United States Duke Health Full time

    Job SummaryWe are seeking a highly organized and detail-oriented individual to join our team as a Clinical Trials Project Coordinator at Duke Health. This role will play a critical part in the successful design, management, and completion of projects on clinical trial methodologies.Key ResponsibilitiesConduct landscape assessments, including literature scans...

  • Clinical Care Coordinator

    1 week ago

    Durham, North Carolina, United States Select Source International Full time

    Job OverviewPosition: Clinical Care CoordinatorLocation: RemoteDuration: 3+ Months with potential for extensionRole SummaryThis position is focused on supporting Medical Necessity assessments. Candidates should possess prior authorization experience and familiarity with Medicare, Case Utilization, and Care Radius is advantageous. A Registered Nurse (RN) with...

  • Cardiometabolic Clinical Pharmacist

    14 hours ago

    Durham, United States Duke University Full time

    At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together.About Duke University HospitalPursue your passion for caring with Duke University Hospital in Durham, North Carolina,...

  • Senior Clinical Research Specialist

    2 weeks ago

    Durham, North Carolina, United States Indotronix Avani Group Full time

    Position Overview:The Senior Clinical Research Specialist plays a pivotal role in overseeing the integrity of data within internal studies. This position collaborates closely with Study Directors to guarantee thorough and prompt data evaluations across all facets of GLP and Preclinical Functionality studies.Key Responsibilities:Serve as the Primary Data...

  • Senior Clinical Research Specialist

    2 weeks ago

    Durham, North Carolina, United States Indotronix Avani Group Full time

    Position Overview:The Clinical Research Scientist will play a pivotal role in ensuring the integrity and compliance of preclinical studies. This position requires a meticulous approach to data evaluation and collaboration with various stakeholders.Key Responsibilities:Serve as the Primary Data Reviewer for internal research initiatives, collaborating closely...

  • Manager Clinical Data Management

    2 months ago

    Durham, United States Aperio Clinical Outcomes Full time

    The OpportunityThe Manager, Clinical Data Management is a data management and people guru. This person is responsible for the strategic leadership of data management staff. We need a coach and mentor who lives to learn, share, and help others grow. The Manager, Clinical Data Management is ultimately responsible for their teams’ projects and at times, may...

  • Manager Clinical Data Management

    3 months ago

    Durham, United States Aperio Clinical Outcomes Full time

    The OpportunityThe Manager, Clinical Data Management is a data management and people guru. This person is responsible for the strategic leadership of data management staff. We need a coach and mentor who lives to learn, share, and help others grow. The Manager, Clinical Data Management is ultimately responsible for their teams’ projects and at times, may...