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Detalles del trabajo
Area del puesto: Servicios Generales / Varios
Publicación:
hace 3 años
Ubicacion del puesto:
Florida - Estados Unidos
Trabajo remoto:
No
Descripción
Description
SHIFT: No WeekendsSCHEDULE: Full-time
HCA Research Institute, the non-oncology service line of Sarah Cannon, encompasses numerous hospitals in different states across the country including Tennessee, Georgia, Virginia, Florida, South Carolina, Texas, Colorado, and California.
HCA Research Institute has conducted over 300 industry-sponsored trials and enrolled more than 3,600 patients since the program’s inception providing innovative approaches to clinical trial management.
Since 2007, the network has grown to 20 hospital programs across the country working in collaboration with more than 325 physician investigators in multiple specialties including cardiovascular disease, neuroscience, orthopedics, robotics and women and children’s services.
Benefits:
•Tuition Reimbursement/Assistance Programs
•Paid Personal Leave
•401k (100% annual match – 3%-9% of pay based on years of service)
•Identity Theft Protection discounts
•Auto, Home, and Life Insurance options
•Adoption Assistance
•Employee Stock Purchase Program (ESPP)
As a Clinical Research Coordinator your primary responsibility is to screen, enroll and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. You are responsible for all data collection, source documentation, completing study specific case report forms, and submission of adverse experience reports.
•You will support enrolling patients onto clinical trials through recruitment, screening, enrollment and follow up of eligible subjects according to protocol requirements
•You will be responsible for working with the principal investigator to meet or exceed study enrollment.
•You will review the study design and inclusion/exclusion criteria with physician and patient
•You will ensure the protection of study patients by verifying informed consent procedures and adhering to protocol requirements/compliance
•You will ensure 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
•You will create study specific tools for source documentation when not provided by sponsor
•You will collect, complete, and enter data into study specific case report forms or electronic data capture systems
•You will generate and track drug shipments, device shipments, and supplies as needed
•You will report and follow up on serious adverse events as necessary
•You will implement study-specific communications
•You will ensure timely adherence to protocol requirements
•You will be responsible for completion of all required documentation according to site works guidelines
•You will ensure timely and accurate data completion
•You will 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
•You will track and report adverse events, serious adverse events, protocol waivers, deviations, and violations
•You will communicate all protocol-related issues to appropriate study colleagues or manager
•You will attend study specific on site meetings, investigator meetings, conference calls and monthly CRC meetings as required or asked to do so
•You will apprise the principal investigator, Research Operations Director and Regional Site Manager of all study specific medical issues for guidance
•You will assist sponsor and US FDA audit teams
•You will review and respond to any monitoring and auditing findings and escalates issues defined by Regional Site Manager
•You will review the study design and inclusion/exclusion criteria with physician and patient
•You will ensure the protection of study patients by verifying informed consent procedures and adhering to protocol requirements/compliance
•You will ensure 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
•You will create study specific tools for source documentation when not provided by sponsor
•You will collect, complete, and enter data into study specific case report forms or electronic data capture systems
•You will generate and track drug shipments, device shipments, and supplies as needed
•You will report and follow up on serious adverse events as necessary
•You will implement study-specific communications
•You will ensure timely adherence to protocol requirements
•You will be responsible for completion of all required documentation according to site works guidelines
•You will ensure timely and accurate data completion
•You will 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
•You will track and report adverse events, serious adverse events, protocol waivers, deviations, and violations
•You will communicate all protocol-related issues to appropriate study colleagues or manager
•You will attend study specific on site meetings, investigator meetings, conference calls and monthly CRC meetings as required or asked to do so
•You will apprise the principal investigator, Research Operations Director and Regional Site Manager of all study specific medical issues for guidance
•You will assist sponsor and US FDA audit teams
•You will review and respond to any monitoring and auditing findings and escalates issues defined by Regional Site Manager
Qualifications
You should have for this position:
•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
•At least one year of experience as a Clinical Research Coordinator
•Cardiology research experience is preferred
•Nursing experience is preferred
•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
•At least one year of experience as a Clinical Research Coordinator
•Cardiology research experience is preferred
•Nursing experience is preferred
Do you want to be a part of a teamworking together to end cardiovascular disease? We look forward to speaking with youabout this phenomenal opportunity. Apply to hear more.
We are anequal opportunity employer and value diversity at our company. We do notdiscriminate on the basis of race, religion, color, national origin, gender,sexual orientation, age, marital status, veteran status, or disability status.
Notice
Our Company’s recruiters are here to help unlock the next possibility within your career and we take your candidate experience very seriously. During the recruitment process, no recruiter or employee will request financial or personal information (Social Security Number, credit card or bank information, etc.) from you via email. The recruiters will not email you from a public webmail client like Gmail or Yahoo Mail. If you feel suspicious of a job posting or job-related email, let us know by clicking here.
For questions about your job application or this site please contact HCAhrAnswers at 1-844-422-5627 option 1.
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