Clinical Research Associate

University of South Florida•Tampa, FL

About The Position

This position typically reports to the principal investigator of a clinical research study. The position may perform evaluation duties in preparation for the project. The position then performs project activities such as overseeing the screening and enrollment of potential clients for a health services protocol, developing materials to communicate the project to potential clients and their families, coordinating site visits and appropriate collection of data, ensuring quality control in the data, and compiling regulatory reports. This position may require specific computer expertise and may require maintaining information on a web site. Work at this level meets the FLSA criteria for a professional exemption since the primary duties are work that requires advanced knowledge which is predominantly intellectual in character and requires the consistent exercise of discretion and judgment. Clinical Research Administrators are not overall project directors. They do not set overall project direction nor do they have responsibility for final interpretation of project results. This position may perform a small amount of general administrative duties such as monitoring budgets, and drafting administrative forms and reports. Work is distinguished from an Administrative and Business Analyst through its primary emphasis on overseeing client recruiting and testing, and analyzing clinical data rather than general administrative work. This position is Grant Funded. This position is eligible for Visa Sponsorship.

Requirements

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.
Senate Bill 1310- The Florida Senate (https://www.flsenate.gov/Session/Bill/2023/1310) is conditional upon meeting all employment eligibility requirements in the U.S.
SB 1310: Substitution of Work Experience for Postsecondary Education Requirements
A public employer may include a postsecondary degree as a baseline requirement only as an alternative to the number of years of direct experience required, not to exceed: (a) Two years of direct experience for an associate degree; (b) Four years of direct experience for a bachelor’s degree; (c) Six years of direct experience for a master’s degree; (d) Seven years of direct experience for a professional degree; or (e) Nine years of direct experience for a doctoral degree
Related work experience may not substitute for any required licensure, certification, or registration required for the position of employment as established by the public employer and indicated in the advertised description of the position of employment.
Minimum Qualifications that require a high school diploma are exempt from SB 1310.

Responsibilities

Serve as key personnel for administrative and clinical coordination, including documentation, IRB file preparation, application/report, and human sample collection and processing/storage in the operating room and lab.
Collaborated closely with principal investigators, physicians, and nurses to align biology, clinical, and functional measures.
Utilize molecular tools and ELISA, and proteomic assays to obtain quantitative gene /protein data and identify disease- and treatment-specific biomarkers.
Perform RNA sequencing, NanoString gene expression profiling, and ELISA assays on blood serum and tissue samples to identify differential protein and pathway expressions.
Collect and analyze genomic data from Single Cell RNA Seq.
Perform immunohistochemistry (IHC), microscopy, and tissue preparation for downstream translational analyses.
Perform human samples related research bench-work.
Extract and curate clinical data from EPIC for over 500 participants, requiring meticulous attention to detail and the ability to interpret complex clinical notes efficiently.
Collaborate with researchers and the lab manager to prepare reagents, manage inventory, and maintain long-term tissue and sample storage.
Serve as a liaison between patients and physicians by collecting patient-reported symptoms, medication-related questions, and concerns, and accurately communicating provider guidance back to patients.
Schedule, manage and interpret doctor notes for patient appointments including eCW and EPIC.
Professional compassionate communication with patients and resolving patient concerns and complaints calmly.
Serve as the central project coordinator, organizing meetings between physicians, clinical researchers, and trainees, ensuring consistent communication and efficient workflow across teams.
Maintain a HIPAA-compliant REDCap database, safeguarding patient confidentiality and ensuring regulatory compliance while managing clinical data.
Lead the coordination of a multidisciplinary collaboration between Cardiovascular Surgery, and Cardiovascular Medicine to generate novel data on cardiovascular health outcomes in patients with coronary heart disease.
Identify and track eligible patients, recording longitudinal treatment data, clinical outcomes, and side effects to assess treatment efficacy.
Apply advanced statistical analyses in MATLAB and RStudio to interpret large-scale clinical datasets and derive biologically and physiologically meaningful conclusions.
Manage and curate clinical trial data in Excel, Tableau, and OneNote, ensuring data integrity, version control, and transparent communication across collaborators.
Present research findings through manuscripts, posters, and oral presentations, communicating complex scientific concepts to both clinical and academic audiences.
Perform other duties as assigned.