Clinical Research Coordinator I

Clinical Research Coordinator I

The Clinical Research Coordinator I is responsible for coordinating and performing research related activities for clinical research projects as assigned. The primary purpose of this position is to oversee the screening, enrollment, and retention of study participants, ensuring quality data collected throughout the research study and implementing the procedures and activities under the direction and oversight of the lead coordinators and principal investigators of the projects.

Monday-Friday, 8:00AM - 5:00PM., In-Office

Responsibilities

• Provides direct support to lead coordinator or coordinate and serve as project lead for projects that are simple to moderate in complexity at the site level.

• 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. Participates in the screening, enrollment, and retention of study participants at the site.

• Conducts study visits and data collection throughout research study.

• Assist with implementation of procedures and activities of assigned study protocols at the site.

• Communicates and collaborates with the study team and clinical team delegated on site specific protocols.

• Collaborates with the preparation and submission of site study documents.

• Assist with coordination, preparation, and conduct of site monitoring visits, audits and inspection.

• Assist with site inventory maintenance (order materials necessary for research projects or lab activities) and other vendor follow-up items (lab report retrieval, medical record retrieval).

• Monitor clinical study activity at the site to ensure compliance with the protocol, site SOPs (Standard Operating Procedures) and all applicable regulations, including HIPAA (Health Insurance Portability and Accountability Act) regulations.

• Performs other duties as assigned.

Qualifications

• Bachelor's degree in a related field -OR- equivalent combination of education and experience.

• Senate Bill 1310- The Florida Senate is conditional upon meeting all employment eligibility requirements in the U.S.

• 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.