Clinical Research Nurse

Institute For Medical Research Inc•Durham, NC

2d•$83,300 - $98,000•Onsite

About The Position

The Institute for Medical Research (IMR), an affiliate of the Durham VA Health Care System (DVAHCS), is seeking a Clinical Research Nurse to support clinical research studies led by Dr. Christopher Woods and his team. This role primarily focuses on vaccine studies but may involve assisting with other industry clinical trials or observational research. Key responsibilities include participant recruitment, enrollment, and follow-up; administering study drugs; collecting and processing biospecimens; managing research data; and ensuring regulatory compliance. This is a patient-facing position requiring 4-5 days a week in-office at the Durham VA Medical Center.

Requirements

Bachelor's degree from an accredited nursing program.
1-2 years full-time relevant clinical nursing experience.
1-2 years clinical research experience.
RN licensure in the state of North Carolina.
BLS certification.
Must reside within the State of North Carolina and maintain a reasonable commuting distance to the assigned work location.

Responsibilities

Coordinate and oversee assigned clinical research studies in accordance with approved protocols.
Provide input related to study budgets, timelines, staffing, scheduling, and operational needs.
Develop, implement, and manage study procedures.
Identify, screen, recruit, and consent eligible research participants.
Administer study drug as directed by research study protocols.
Conduct participant follow-up visits and maintain ongoing engagement.
Apply sound judgment and problem-solving skills to address protocol deviations, recruitment challenges, and operational barriers.
Coordinate with study sponsors, contractors, Principal Investigators, and research team members for sponsored or multi-site studies.
Plan, provide, supervise, and document professional nursing care utilizing the nursing process for patients in accordance with study protocols, Principal Investigator orders, and established policies and procedures.
Use professional nursing judgment when conducting nursing research activities to patients.
May delegate tasks and supervise the activities of other licensed and unlicensed research staff.
Monitor and initiate corrective action to maintain the environment of care, including equipment and material resources.
Participate in the identification of clinical or operational performance improvement opportunities and in performance improvement activities.
Prepare and submit protocols, informed consent forms, HIPAA authorizations, and other regulatory documents for IRB review.
Prepare and submit amendments, continuing reviews, audits, adverse event reports, and other IRB-required documentation.
Maintain regulatory binders and documentation in collaboration with administrative staff.
Maintain accurate digital and/or paper study records, including informed consent forms, HIPAA documentation, case report forms, EMR research documentation, and participant payment records.
Review study records and binders for completeness, accuracy, and compliance with applicable regulations.
Resolve missing or inaccurate documentation and follow up with study participants as needed.
Assist with and train staff on procurement, processing, storage, and shipment of biospecimens.
Coordinate biospecimen handling, including blood, swabs, and, when applicable, urine and stool samples.
Facilitate shipment and receipt of specimens to and from external laboratories or facilities.
Ensure biospecimen processing procedures are followed accurately and consistently.
Manage day-to-day operational decisions related to assigned study protocols.
Collaborate with other Clinical Research Coordinators to ensure study milestones and objectives are met.
Update and maintain standard operating procedures (SOPs).
Participate in study meetings, conference calls, and leadership discussions.
Support current and future collaborations with clinical departments and VHA research partners nationwide.