Clinical Research Coordinator

posted:
Location
Port Saint Lucie, Florida
Industry
Health & Social Care, Practitioner & Technician (Healthcare Practitioners and Technical Occupations)
Job Type
Temp to Perm
Working Hours
8:00 AM - 5:00 PM
Salary
US$ 15.00 per hour
Ref. Number
S_34739
Contact
Justin Kolleda, Spherion
Phone
7723369545 X208
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Job Description

Coordinates clinical research trials for various pharmaceutical companies under the supervision of the Research Director. Ensures quality, consistency, and accuracy in the data entry with clinical research eCRF's. Manage multiple duties while ensuring attention to detail. Maintain regulatory documents. Perform duties as designated by protocol. Specimen processing and shipping per IATA guidelines. Record and report adverse events, maintain source documents and case report forms. Scheduling monitoring, site-initiation, and close-out visits with research monitors. Communicate with study sponsors. Assist with procedures designated by protocol, query response.

Responsibilities:
ESSENTIAL JOB FUNCTIONS :
- Develop source documents for new clinical research projects
- Coordinate meetings with sponsors and study monitor for review of data
- Conduct the clinical study according to FDA regulations and guidelines
- Prepares daily visits for each subject based on protocol schemas
- Reporting of SAE to Sponsor and Regulatory agency
- Maintains updated patient logs in study
- Calls to IWRS for visits
- Schedule visits with CRA's
- Answer queries in eCRF system
- Reviews and maintain all medical and regulatory data
- Performs chart audits to ensure compliance and completeness of records
- Keep Director and RNs informed of all new amendment or/and consents
- Maintain RECIST worksheets for tumor assessment

SECONDARY JOB FUNCTIONS:
- File reports with IRB for deviations
- Forward any data required to sponsor while maintaining HIPPA standards at all times
- Telephone triage, scheduling and coordinating outside services required
- Shipping of samples to assigned location per sponsor

Working hours: 8:00 AM - 5:00 PM

Skills:
- Must have 3 + years medical or health field experience, oncology experience preferred.
- Experience in clinical research, and prior use of Good Clinical Practice(GCP) requirements and medical documentation is desired.
- Minimum 6 months experience of clinical research in the areas of enrollment, monitoring and reporting data on clinical studies.

Education:
High School

Experience:
1-4 years

Qualifications:
LICENSES/CERTIFICATION:
- GCP Certificate and Human Protection Certificate either upon hire or successfully complete the course with 6 months of hire.


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Spherion has helped thousands of people just like you find work happiness! Our experienced staff will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temp-to-perm or direct hire opportunities, no one works harder for you than Spherion. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.

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