CLINICAL RESEARCH NURSE COORDINATOR

Duke Careers•Durham, NC

1d•$66,265 - $107,096•Onsite

About The Position

This CRNC position is embedded within the DHVI CRU, crossing all age groups, from Pediatrics, to Adults and Older Adults. We participate in all phases of studies, typically Phase 2/3. Study team members work as a whole to integrate communication, participant safety and overall team goals being met.

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.
Twelve months of appropriate clinical nursing experience is required.

Nice To Haves

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.

Responsibilities

Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs.
Serves as expert resource and trainer to implement and comply with systems for managing and documenting investigational product (IP).
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 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.
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.
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.
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.).
Independently uses and implements technology to enhance productivity or process.
Under guidance, develops sections of protocols for simple studies (e.g., registries, survey studies).
Demonstrates a basic understanding of the elements of research study designs.
Provides some contribution to scientific publications or presentations (no authorship).
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.
Collects appropriate information to determine whether the study team's participation in a specific trial is feasible.
For studies with complex 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, and may develop or implement, protocol-specific systems and documents including process flows.
Prepares studies for closeout and document storage.
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.).
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.
Ambulatory Medication Administration
Adult Medication
Pediatric Medication