CLINICAL RESEARCH NURSE COORDINATOR

Duke Careers•Durham, NC

10d•$63,692 - $102,937•Onsite

About The Position

This position will serve as the primary nurse coordinator for clinical studies in the Division of Hematology. The coordinator will conduct clinical research studies in the areas of benign Hematology and Sickle Cell Disease, as well as serve as back up for studies as needed. The nurse coordinator will be responsible for all day to day study activities (such as subject consent and enrollment, data collection and entry, participant compensation, study monitoring activities, etc.), and will work with the Division Lead to manage regulatory tasks (such as study start up and close out, IRB tasks, etc.). The person in this role must have organizational skills, communication skills, the ability to handle multiple assignments simultaneously, technology skills, medical terminology, and understanding of clinical medicine. They must be able to flex with the demand of work schedules and timelines. They must demonstrate excellent attention to detail. They must be able to manage, work with, and support multiple stakeholders with different practice styles in a productive manner, and willing to learn new and complex skills as needed. The nurse coordinator must be resourceful, able to work independently, and to problem-solve on a daily basis. The preferred candidate will have Duke clinical trial experience and a desire to expand their knowledge and to share knowledge in an academic setting.

Requirements

Graduation from an accredited BSN or Associates Degree in Nursing or Nursing Diploma program.
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.

Nice To Haves

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.
Duke clinical trial experience.
A desire to expand their knowledge and to share knowledge in an academic setting.

Responsibilities

Plan, provide, supervise, and document professional nursing care utilizing the nursing process for patients in accordance with physician orders and established policies and procedures.
Use professional nursing judgment when conducting nursing research activities to patients.
Monitor and initiate corrective action to maintain the environment of care, including equipment and material resources.
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.
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.
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.
Contributes to the effective facilitation of team meetings to achieve predetermined objectives.
May lead multidisciplinary meetings with various stakeholders.
Identifies all AEs, 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 Maestro Care.
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.
Enters and collects data.
Develops data entry or collection SOPs or tools.
With supervision, responds to queries created by a CRO or the data manager.
Assists with quality control and data cleaning as directed.
Ensures accuracy and completeness of data for all studies, including those that are complex in nature.
Recognizes data quality trends and escalates as appropriate.
Recognizes and reports security of physical and electronic data vulnerabilities.
Develops or reviews data lifecycle and management plans for multiple study protocols.
Maps a protocol's data flow plan including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.).
Innovatively uses technology to enhance a research process.
Assists with or contributes to the development of funding proposals.
Independently conducts literature searches and reviews.
Demonstrates and applies a basic understanding of open science practices and the FAIR data principals.
Using scientific proposals from the PI, develops elements of research protocols.
Demonstrates a basic understanding of the elements of research study designs.
Contributes to the development of scientific publications or presentations.
Serves as an author on poster presentations or publications.
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.
Uses clinical research management system and its reports to manage all protocol activities, including minimum footprint, SIP counsel, and all aspects of maintaining current protocol information.
Collects appropriate information to determine whether the study team's participation in a specific trial is feasible.
For studies with 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.
Follows, and may develop or implement, operational plans (e.g. protocol-specific systems and documents including process flows).
Prepares studies for closeout and document storage.
Proactively seeks opportunities to add relevant skills and certifications to own portfolio.
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.
Serves on committees and workgroups internal to Duke or externally in therapeutic area of research.
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.
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.