Clinical Research Coord II

University of South Florida•Tampa, FL

About The Position

This position is not eligible for Visa Sponsorship This position typically reports to the Principal Investigator, Clinical Research Manager, or a Lead Clinical Research Coordinator. Working under general supervision, the Clinical Research Coordinator II is responsible for the coordination of more complex clinical research related activities, including but not limited to maintenance of regulatory documents, screening and enrolling patients, collecting biospecimens, performing clinical tasks as appropriately trained and delegated, data collection and entry, coordinating study and monitoring visits, and submitting reports as needed. Work at this level meets the FLSA criteria for a professional exemption since the primary duties are directly related to the clinical studies operations, requiring advanced knowledge and the application of discretion and independent judgment on matters of significance with respect to clinical study protocols, quality data and coordination of operational activities. This position differs from the Clinical Research Coordinator I classification by providing independent coordination of multiple, complex clinical research studies.

Requirements

This position requires a Bachelor's degree in a related field and two (2) years of relevant experience in a clinical setting or clinical research experience.
A combination of Education and/or experience can substitute for the minimum requirements.
Degree Equivalency Clause: Four years of direct experience for a bachelor’s degree.
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.
Some positions may require certification in phlebotomy or obtain certification within six (6) months of employment.
Comprehension of clinical research principles, Good Clinical Practice Guidelines, and regulatory requirements.
Attention to detail, critical thinking, ability to follow protocols, Ability to maintain quality standards, planning and scheduling, data collection, clear communication, and organization.
Ability to communicate and interact competently and professionally at all levels within a broad, complex clinical research environment.
Ability to provide technical advice, guidance, and support to professional and support staff
Skill in the use of personal computers and related software applications.

Responsibilities

Plans, organizes, and manages the resources necessary to achieve clinical research project goals and objectives at a single site.
Coordinates and performs patient clinical assessments for clinical trial visits for assigned clinical trial protocols including scheduling with vendors which may include other departments or outside facilities. This may include phlebotomy, sample processing, vitals, ECGs and other delegated clinical assessments per assigned protocols.
Communicates as a site representative with study sponsors, third party vendors, clinical teams and patients to ensure all protocol required elements are being completed and collected within the defined windows.
Ensures site compliance with research protocols, reviews case report forms and audits for accuracy with source documents, attends site monitoring meetings with sponsors.
Manages the site research project databases, develops flowsheets and other study related documents, and completes source documents/case report forms.
May provide guidance to other clinical research staff and support personnel.
Makes recommendations of procedures in order to facilitate protocol compliance.
Performs data entry and query resolution during the duration of each trial assigned.
Serve as a resource for both internal and external customers and members of the community in regard to clinical research processes at the site.
Performs other duties as assigned.