School of Medicine:

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Duke’s Department of Obstetrics and Gynecology has an immediate opening for a Clinical Research Nurse Coordinator located at the Duke Perinatal Research Center located at 2608 Erwin Road, Suite 210, Durham, NC 27705.

https://obgyn.duke.edu/research/active-research-programs/duke-perinatal-research-center

Occupational Summary

100% Grant funded

Participate in or lead day-to-day operations of clinical research studies conducted by principal investigator(s) at Duke Medicine; perform a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. May oversee the work of junior staff and train or mentor others in clinical research tasks. Provide and document professional nursing care for research participants. Research population involves obstetric patients with studies which are minimal or possibly greater than minimal risk and complexity. On-call rotation will be required with this position.

Work Performed

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.

- 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. - Employs strategies to maintain retention rates. Evaluates 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 Standard Operating Procedures (SOPs).

– Collects, prepares, processes, ships, and maintains the inventory of 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 and plans for complex study visits.

- Participates in study team meetings.

Ethics:

- Identifies all Adverse Events (AE), and determines whether or not they are reportable.

- Collaborates with the PI 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 EPIC.

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

- 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. - Independently uses and implements technology to enhance productivity or 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, including minimum footprint, calendars, tracking/marking financial milestones, and all aspects of study visits.

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

- Ensures that studies are conducted in compliance with institutional requirements and other policies.

- Follows protocol-specific systems and 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 departmental meetings (i.e. Research Wednesday, RPN, additional training, etc.).

- 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.

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

Description of Clinical Responsibilities/Preferred Skills:

Clinical responsibilities:
• Ambulatory Medication Administration and Adult Medication

Obstetrics experience preferred

Minimum Qualifications

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 berequired 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).

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 essentialjob 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.