Clinical Research Nurse
at HCA Healthcare
Nashville, TN 37203, USA -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 29 Jul, 2024 | Not Specified | 01 May, 2024 | 1 year(s) or above | Screening,Computer Skills,Clinical Research Experience,Clinical Trials,Communication Skills,Regulations,Interpersonal Skills,Clinical Practices,Deviations,Case Report Forms,Reviews,Adverse Events,Federal Regulations,Completion,Excel,Document Review | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
OPT | H4 Spouse of H1B |
GC Green Card |
Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
Description:
INTRODUCTION
Are you passionate about the patient experience? At HCA Healthcare, we are committed to caring for patients with purpose and integrity. We care like family! Jump-start your career as a Clinical Research Nurse today with HCA Healthcare.
JOB SUMMARY AND QUALIFICATIONS
The Clinical 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.
Job Responsibilities:
- Supports enrolling patients onto clinical trials through recruitment, screening, enrollment and follow up of eligible subjects according to protocol requirements.
- Responsible for working with the principal investigator to meet or exceed study enrollment.
- 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.
- Collects, 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.
- Ensures timely adherence to protocol requirements.
- Responsible for completion of all required documentation according to site works guidelines.
- 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.
- 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.
- Assists sponsor and US FDA audit teams.
- Reviews and responds to any monitoring and auditing findings and escalates issues defined by Regional Site Manager.
You should have:
- 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
Education & Experience:
- Associate Degree in Nursing required; Bachelor Degree preferred
- Active LPN or RN license in the state of practice required
- 1-2 years of clinical research experience preferred
NOTE: ELIGIBILITY FOR BENEFITS MAY VARY BY LOCATION.
“The great hospitals will always put the patient and the patient’s family first, and the really great institutions will provide care with warmth, compassion, and dignity for the individual."- Dr. Thomas Frist, Sr.
HCA Healthcare Co-Founder
If you are looking for an opportunity that provides satisfaction and personal growth, we encourage you to apply for our Research Nurse opening. We promptly review all applications. Highly qualified candidates will be contacted for interviews. Unlock the possibilities and apply today!
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status
Responsibilities:
- Supports enrolling patients onto clinical trials through recruitment, screening, enrollment and follow up of eligible subjects according to protocol requirements.
- Responsible for working with the principal investigator to meet or exceed study enrollment.
- 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.
- Collects, 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.
- Ensures timely adherence to protocol requirements.
- Responsible for completion of all required documentation according to site works guidelines.
- 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.
- 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.
- Assists sponsor and US FDA audit teams.
- Reviews and responds to any monitoring and auditing findings and escalates issues defined by Regional Site Manager
REQUIREMENT SUMMARY
Min:1.0Max:2.0 year(s)
Hospital/Health Care
Pharma / Biotech / Healthcare / Medical / R&D
Health Care
Graduate
Proficient
1
Nashville, TN 37203, USA