Clinical Research Coord I
About The Position
Incumbent will be responsible for the daily operation of biobanking initiatives run by the Fixel Institute. Responsibilities include chart review, identification and recruitment of research subjects, proper consenting of subjects, bio sample(s) and data collection, and data entry. The incumbent will administer clinical, epidemiologic and genealogic questionnaires, in person, and accurately enter that information into a database. Incumbent will be responsible for obtaining biospecimen samples (i.e., blood draws, saliva), processing, cataloging, and storing samples. Incumbent will be responsible for coordinating with various UF biobanks and proper handling of specimens. Coordinate research sample collection with clinical and research personnel to obtain samples. Ensure that research samples are processed according to protocol or sponsor requirements. Ensure that research samples are stored appropriately. Prepare samples for shipment as required by the protocol and ship samples in accordance with protocol, local, state and federal requirements. Regulatory management. Facilitate internal and external inspections and audits of subject medical records to ensure compliance with the protocol. Prepares cumulative adverse event tables and deviation reports as required for continuing review or closure reports. Facilitates the accurate reporting of continuing review/study closure reports, serious adverse event reports, protocol revisions and other documents to the IRB. Submits documents into established workflows within appropriate timelines to prevent project expiration or sponsor deficiencies. Reviews all finalized IRB submissions packets for accuracy and completeness prior to submission and tracks all submissions to their final status to verify completion. Enters and tracks all regulatory information in the Clinical Trials Management System. Ensures that all approval documents are filed in regulatory and/or study binders. Attends conferences/meetings as a representative of the Fixel Institute Research Program. Maintain proper training and certifications.
Requirements
- Associate’s degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience.
Nice To Haves
- Demonstrated ability to work independently, interact professionally, and effective writing and organizational skills.
- Excellent time management skills and ability to successfully manage multiple priorities.
- Phlebotomy certification or significant phlebotomy experience is preferred.
- Proficient in Microsoft Office Suite, Training in REDCap
Responsibilities
- Chart review
- Identification and recruitment of research subjects
- Proper consenting of subjects
- Bio sample(s) and data collection
- Data entry
- Administer clinical, epidemiologic and genealogic questionnaires
- Obtaining biospecimen samples (i.e., blood draws, saliva), processing, cataloging, and storing samples
- Coordinating with various UF biobanks and proper handling of specimens
- Coordinate research sample collection with clinical and research personnel to obtain samples
- Ensure that research samples are processed according to protocol or sponsor requirements
- Ensure that research samples are stored appropriately
- Prepare samples for shipment as required by the protocol and ship samples in accordance with protocol, local, state and federal requirements
- Regulatory management
- Facilitate internal and external inspections and audits of subject medical records to ensure compliance with the protocol
- Prepares cumulative adverse event tables and deviation reports as required for continuing review or closure reports
- Facilitates the accurate reporting of continuing review/study closure reports, serious adverse event reports, protocol revisions and other documents to the IRB
- Submits documents into established workflows within appropriate timelines to prevent project expiration or sponsor deficiencies
- Reviews all finalized IRB submissions packets for accuracy and completeness prior to submission and tracks all submissions to their final status to verify completion
- Enters and tracks all regulatory information in the Clinical Trials Management System
- Ensures that all approval documents are filed in regulatory and/or study binders
- Attends conferences/meetings as a representative of the Fixel Institute Research Program
- Maintain proper training and certifications
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
Number of Employees
1-10 employees
