CLINICAL RESEARCH NURSE COORDINATOR
Durham, NC, US, 27710
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.
Be You.
The Department of Dermatology is looking for a Clinical Research Nurse Coordinator to join our team. This position will be an integral part of all industry clinical trials, and any prospectively enrolling Principal Investigator initiated studies for the Department of Dermatology. These trials will mostly be investigational drug trials of all phases, but there are also device trials that may occur. The population will generally be adults, but sometimes trials will enroll ages 12 and up.
This position will potentially work with both adult and pediatric participants with a variety of dermatological conditions, including oncology. The position will work on studies of all phases with a small team at multiple clinical locations.
Minimum Requirements:
The ideal candidate will have prior research experience with comfort in phlebotomy and medication administration.
Education/Training
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 nursing experience is required.
Be Bold.
Position Description:
Operations: Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs.
May train others in these policies and processes.
Is responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research participants. Serves as the primary liaison with sponsors, IDS, and other parties as necessary.
Follows protocol schema for randomization and blinding/unblinding.
Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings.
Maintains participant level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies) and/or require access to the Duke EHR.
Employ strategies to maintain retention rates. Evaluate processes to identify problems with retention.
Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues.. Screens participants for complex studies (e.g., procedural and interventional studies).
Develops or helps develop SOPs. Collects, prepares, processes, ships, and maintains the inventory of human research specimens, primarily those requiring complex procedures.
Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). Conducts activities for study visits in compliance with the protocol. Participates in study team meetings. Ethics: Identifies all Adverse Events(AE), and determines whether or not they are reportable. Collaborates with the Principal Investigator to determine AE attributes, including relatedness to study.
Conducts and documents consent for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care. May train or oversee others. Develops consent plans and documents for participants in a variety of studies.
Develops and submits documentation and information for IRB review. Communicates with the IRB staff and reviewers and handles issues appropriately. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. Data: Enters and collects data. Develops data entry or collection SOPs or tools. May provide oversight or training to study team members collecting or entering data.
Ensures accuracy and completeness of data for all studies, including those that are complex in nature. Recognizes data quality trends and escalates as appropriate. May develop tools for, and train others in, data quality assurance procedures.
Follows required processes, policies, and systems to ensure data security and provenance. In addition, recognizes and reports security of physical and electronic data vulnerabilities. Learns and uses new technology when required. Science: Demonstrates a basic understanding of the elements of research study designs. Study and Site Management: Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CROs.
Uses clinical research management system and its reports to manage research participants' activities, calendars, tracking/marking financial milestones, and all aspects of study visits.
Uses required EMR functionalities to manage participants and study visits. Records basic protocol information in clinical research management system. Collects appropriate information to determine whether the study team's participation in a specific trial is feasible. May make recommendations.
For studies with supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. May forecast effort needs. Ensure that studies are conducted in compliance with institutional requirements and other policies. Follow, and may develop or implement, operational plans (e.g. protocol-specific systems and documents including process flows). Prepares studies for closeout and document storage. Leadership: Works with the manager to understand areas of opportunity and develop a training plan. Takes training courses and applies the knowledge and skills. May also train others in the skills learned.
Keeps current with research updates by attending key external departmental meetings (i.e. Research Wednesday, RPN, additional training, etc.).
Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently. Demonstrates resilience and is adaptive to change. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives. Clinical responsibilities: • Ambulatory Medication Administration • Adult Medication• Pediatric Medication • Peripheral IV Insertion and Maintenance • Adult Chemotherapy Administration
Choose Duke.
Join our award-winning team and be part of an inclusive culture that values excellence, innovation, and discovery. Duke University is consistently ranked among the top universities worldwide and is renowned for its cutting-edge research across disciplines. Beyond the engaging work, you'll also benefit from Duke's competitive benefits package, including health insurance plans, generous paid time off, retirement programs with employer contributions, tuition assistance for employees and their children, and more.
Screening of Applications: Screening continues until the position is filled.
Anticipated Pay Range:
Duke University provides an annual base salary range for this position as USD $ 63692 to USD $102,937. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate 's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.
Your total compensation goes beyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at https://hr.duke.edu/benefits/
Duke is an 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 (including pregnancy and pregnancy related conditions), sexual orientation or military status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends onthe 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.
Nearest Major Market: Durham
Nearest Secondary Market: Raleigh