Clinical Research Associate

Dept Number/Name: 0-6119-000 / Dept of Pediatrics
College Division: USF Health- Morsani College of Medicine
Salary Plan: Administrative - Grant Funded (Time limited for 1 year. Based on grant/clinical trials funding)
Job Code/Title: 4728 / Clinical Research Associate
Hiring Salary/Salary Range: $45,000 - $46,000 annual
Position Number: 00042311
ORGANIZATIONAL SUMMARY:
This position supports the division of Allergy Immunology in the Department of Pediatrics. The Division of Allergy and Immunology was founded in 1984 at All Children's Hospital/Johns Hopkins Medicine in St. Petersburg, Florida by Dr. Robert Good. The Division includes clinical programs that encompass primary immunodeficiency diseases, pediatric and adult allergy, and pediatric rheumatology, and pediatric secondary immunodeficiencies.
POSITION SUMMARY:
This position will support research grants. The primary purpose of this position is to recruit and retain study subjects while coordinating their visits and managing data gathered as a result of their participation in federal, investigator initiated, and sponsored research projects. Will screen recruit and enroll patients in trials. Will follow patients through the trials until completion. Will complete and ensure accuracy of regulatory documentation.
RESPONSIBILITIES:
Oversee clinical trials: start-up process of clinical trial onboarding, site preparation for trial endeavors (i.e. coordinating supply shipment, pharmacy preparations, proper certifications and documentation, etc.), communicating with sponsors, spearheading trial audits and FDA inspections
Execute patient visits: Perform all study procedures that do not need to be completed by PIs/Sub-Is/other licensed medical workers, perform study assessments (including by not limited to electrocardiograms, phlebotomy, walk tests, status assessments, etc.), process and ship any samples collected during the visit, communicate with PI/Sub-Is and sponsors to ensure proper execution, oversee scheduling and preparation arrangements leading up to visits
Oversee other clinical trial personnel: training research support specialists and study coordinators on general clinical trial practices, assisting with onboarding process, providing guidance on performing basic clinical procedures and patient assessments, educating on research tenants and other miscellaneous practice guidelines
Manage site operations related to clinical trials: create and maintain site documentation of standard operation procedures (SOPs), certifications, calibration records, temperature logs, etc., improve upon outdated or incomplete site manuals or records, ensure proper equipment and supplies as relates to clinical trials are available on site, maintain regulatory documentation for all ongoing and archived protocols
Manage Newborn Screening Program: receive program referrals, act as liaison between onsite physician providers and state program representatives, establish site-level SOPs for program, maintain database for referral statuses, submit quarterly reports, complete and submit case report form
Performs other duties as assigned.
POSITION QUALIFICATIONS:
MINIMUM:
This position requires a Bachelor's degree in a field directly related to the program responsibilities and one year of professional experience; or Master's degree in an area of specialization appropriate for the program.

FLSB1310 equivalency:
Four years of directly related experience can be substituted for a Bachelor's degree.
Six years of directly related experience can be substituted for a Master's degree.

Information for Applicants 

This position is subject to a Level 2 criminal background check.

Job Opening Number: 36950

Posting Date: 05/14/2024

Posting End Date: 05/28/2024

How To Apply 

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Apply online by completing the required information and attaching your cover letter and resume. Please include your experience as it relates to the qualifications stated above.  YOUR COVER LETTER AND RESUME, PLUS ANY OTHER REQUESTED MATERIAL, MUST BE IN ONE ATTACHMENT. Only online applications are accepted for this position.

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