Quality Control Coordinator

Company: Covenant Metabolic Specialists
Location: Sarasota
Posted on: November 23, 2022

Job Description:

This position will be responsible for Quality Control (QC) GCP activities. The primary responsibilities will be to ensure quality and compliance of Covenant Research and Clinics clinical trials with respect to Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country specific, and current industry standards and practices) as well as support the non-clinical team on ensuring Covenant Research and Clinics studies are conducted in a compliant manner. This position reports to the Chief Financial Officer/Chief Strategy & Growth Officer.

*Job Duties: *

- Perform routine and non-routine quality control reviews to include but not limited to: in screening; prior to randomization subjects; post randomization subjects; screen fail subjects; completed trial subjects

- Ensure the timely and effective follow up of all identified or assigned quality issues

- Lead in preparing investigational sites for Sponsor and regulatory inspections

- Conduct 100% QC review of all ICFs, Protocol Deviations, SAE's and other clinical trial specified documents

- Conducts 100% Source Data Verification of all Clinic Visits with the corresponding electronic Case Report Forms (eCRFs) for each trial

- Reports trends from QC findings to assure compliance and contiuous improvement

- Schedules and/or delivers monthly QC educational sessions

- Detailed Quality Control Associate Protocol and QC Workflows attached

Job Type: Full-time

Pay: $65,000.00 - $70,000.00 per year

Benefits:
* Dental insurance
* Flexible spending account
* Health insurance
* Life insurance
* Paid time off
* Vision insurance
Schedule:
* 8 hour shift

Work Location: One location%58047475%

Keywords: Covenant Metabolic Specialists, Sarasota , Quality Control Coordinator, Other , Sarasota, Florida