Research Nurse

HCA Healthcare • Asheville, NC

19d • Onsite

About The Position

The Research Nurse coordinates multiple research protocols and serves as a liaison with local investigators, clinical staff, and research personnel. Under direct supervision, the nurse develops an understanding of research operations and regulations and builds a strong foundation in human-subject research. This is a hospital-based role and may include coverage at satellite clinic sites, after-hours, and on weekends as necessary.

Requirements

• Associate’s degree required.
• Active RN license required.
• Knowledge of federal regulations and good clinical practices (GCP).
• Knowledge of medical and research terminology.
• Computer skills, including use of clinical-trial databases, electronic data capture, and Microsoft Word or Excel.
• Excellent verbal and written communication skills.
• Excellent interpersonal skills.
• Ability to communicate and work effectively with a diverse team of professionals.
• Organizational and prioritizing capabilities.
• Ability to work independently in a fast-paced environment with minimal supervision at off-site facilities.

Nice To Haves

• Bachelor’s degree preferred.

Responsibilities

• Support clinical-trial enrollment through recruitment, screening, enrollment, and follow-up of eligible subjects according to protocol requirements.
• Work with the principal investigator to meet or exceed study enrollment goals.
• Review study design and inclusion/exclusion criteria with physicians and patients.
• Protect study participants by verifying informed-consent procedures and adhering to protocol requirements and compliance standards.
• Review source documents carefully to ensure the integrity of data submitted on Case Report Forms and other data-collection tools; monitor for missing or implausible data.
• Maintain adequate and accurate records for inspection and create study-specific source-documentation tools when not provided by the sponsor.
• Collect, complete, and enter data into study-specific case report forms or electronic data-capture systems.
• Generate and track drug shipments, device shipments, and supplies as needed.
• Report and follow up on serious adverse events as necessary; track and report adverse events, protocol waivers, deviations, and violations.
• Implement study-specific communications and ensure timely adherence to protocol requirements and completion of required documentation and data.
• Maintain accurate and complete records, including regulatory documents when applicable, signed informed-consent forms, source documentation, drug-dispensing logs, device-utilization logs, subject logs, and study-related communications.
• Communicate protocol-related issues to appropriate study colleagues or a manager.
• Attend study-specific on-site meetings, investigator meetings, conference calls, and monthly CRC meetings as required or requested.
• Apprise the principal investigator, Research Operations Director, and Regional Site Manager of study-specific medical issues for guidance.
• Assist sponsor and U.S. FDA audit teams; review and respond to monitoring and auditing findings and escalate issues as defined by the Regional Site Manager.
• Maintain patient confidentiality according to ethical and legal requirements.
• Provide coverage for satellite clinic sites, after hours, and on weekends as necessary.

Benefits

• Comprehensive medical, prescription drug, dental, vision, behavioral health, and telemedicine benefits.
• Wellbeing support, including free counseling and referral services.
• Time-away-from-work programs, including paid time off, paid family leave, long- and short-term disability coverage, and leaves of absence.
• Savings and retirement resources, including a 401(k) plan with a 100% match on 3% to 9% of pay based on years of service, an Employee Stock Purchase Plan, flexible spending accounts, preferred banking partnerships, retirement-readiness tools, rollover support, and financial-wellbeing counseling.
• Education support through tuition assistance, student loan assistance, certification support, dependent scholarships, and a partnership with Galen College of Nursing.
• Fertility and family-building benefits and adoption assistance.
• Life insurance and supplemental health-protection plans.
• Auto and home insurance, legal counseling, identity-theft protection, and consumer discounts.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree