Research Nurse

About the role

The Research Nurse is responsible for coordinating multiple research protocols and serving as a liaison with local investigators, clinical staff, and research personnel. Under direct supervision, this individual will mature in their understanding of research operations and regulations in order to achieve a strong fundamental understanding of human subject research.

Responsibilities

• Supports enrolling patients onto clinical trials through recruitment, screening, enrollment and follow up of eligible subjects according to protocol requirements
• Reviews the study design and inclusion/exclusion criteria with physician and patient
• Ensures the protection of study patients by verifying informed consent procedures and adhering to protocol requirements/compliance
• Ensures the integrity of the data submitted on Case Report Forms or other data collection tools by careful source document review; monitors data for missing or implausible data
• Ensures that adequate and accurate records are maintained for inspecting
• Creates study specific tools for source documentation when not provided by sponsor
• Collections, completes, and enters data into study specific case report forms or electronic data capture systems
• Generates and tracks drug shipments, device shipments, and supplies as needed
• Reports and follows up on serious adverse events as necessary
• Implements study-specific communications
• Ensures timely adherence to protocol requirements
• Responsible for completion of all required documentation according to site works guidelines
• Ensures timely and accurate data completion
• Maintains 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
• Tracks and reports adverse events, serious adverse events, protocol waivers, deviations, and violations
• Communicates all protocol-related issues to appropriate study colleagues or manager
• Attends study specific on site meetings, investigator meetings, conference calls and monthly CRC meetings as required or asked to do so
• Apprises principal investigator, Research Operations Director and Regional Site Manager of all study specific medical issues for guidance
• Aids sponsor and US FDA audit teams
• Reviews and responds to any monitoring and auditing findings and escalates issues defined by Regional Site Manager
• Maintains patient confidentiality according to ethical and legal requirements
• Aids in providing coverage for satellite clinic sites as necessary
• Responsible for coverage after hours and on weekends as necessary

Qualifications

• Bachelor’s Degree
• Active RN License required
• Knowledge of federal regulations, good clinical practices (GCP)
• Knowledge of medical and research terminology
• Computer skills including use of clinical trial database, electronic data capture, and MS Word or Excel
• Excellent Verbal and written communication skills
• Excellent interpersonal skills
• The ability to communicate and work effectively with a diverse team of professionals
• Organizational and prioritizing capabilities
• The ability to work independently in a fast pace environment with minimal supervision at off-site facilities

Benefits

HCA Healthcare offers a total rewards package that supports the health, life, career and retirement of our colleagues. The available plans and programs include:

• Comprehensive benefits for medical, prescription drug, dental, vision, behavioral health and telemedicine services
• Wellbeing support, including free counseling and referral services
• Time away from work programs for 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), 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

Note

Note: Eligibility for benefits may vary by location.