Up to $0.00 per year
: Clinical Research Coordinator
: Clinical Research
: Coordinates clinical research trials for various pharmaceutical companies under the supervision of the Research Director. Ensures quality, consistency, and accuracy in the data entry withclinical 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.
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. Designs and maintains organizational tools as needed. 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 RN's informed of all new amendment or/and consents. Maintain RECIST worksheets for tumor assessment. Must know how to multitask.
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. Copying , printing and other minor office procedures. Handle interruptions; work under pressure; set priorities among multiple requests. Handle sensitive and confidential patient information in a professional manner.
: Medical terminology .
: High School Diploma
: 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.
: GCP Certificate and Human Protection Certificate either upon hire or successfully complete the course with 6 months of hire.
: Operating a variety of office equipment including a computer utilizing a variety of software applications and programs. Maintaining department quality assurance with data . Answering phones, instructing and operating electronic devices, sending EKG's/Holters to designated locations per study.
Start Date: ASAP
Position Type: Contractor
Years of Experience Required: