Clinical Research Nurse Coordinator - Obstetrics and Gynecology

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.

Duke University’s Department of Obstetrics and Gynecology as an opening for a Clinical Research Nurse Coordinator located in Durham, NC.

This position is will be part of the Perinatal Research team, which conducts studies in pregnant and postpartum individuals, as well as their babies.  Experience with infants and/or pregnant people is strongly preferred. This position 100% on site.

Operations:

May train or oversee others in all areas listed below. .

Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs.

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, and determines whether or not they are reportable.  Collaborates with the Principal Investigator to determine adverse event 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.

Assists with the development of consent plans and documents for participants.

Under supervision, for non-complex studies (e.g., survey studies and registries), develops and submits documentation and information for IRB review.

 

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.

Knowledgeable about the use of data standard policies. Innovatively uses technology to enhance a research process.

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. For studies with simple supplies or equipment, ensures that there are ample supplies and that equipment is in good working order.

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)..

As directed, assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor).

Leadership:
Works with the manager to understand areas of opportunity and develop a training plan. Takes training courses and applies the knowledge and skills.

Keeps current with research updates by attending key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job.

May disseminate information to others. Serves on committees and workgroups internal to Duke or externally in therapeutic area of research.

Demonstrates interpersonal skills to get work done efficiently. Recognizes and escalates organizational issues that could be optimized to improve research process. Demonstrates resilience and is adaptive to change.

Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems across multiple study teams.

Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.


Clinical responsibilities:
• Ambulatory Medication Administration
• Adult Medication
• Fetal Monitoring
• Other: Infant Heelsticks
 

Minimum Qualifications

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) 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. 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).

Experience

Twelve months of appropriate clinical nursing experience is required.

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 eachhiring department.