Clinical Research Compliance Specialist

4 weeks ago


Tampa, Florida, United States K2 STAFFING LLC Full time
Job Description

We are seeking a detail-oriented and knowledgeable Quality Control Associate to support our clinical research clinics in the greater Tampa, FL area. The successful candidate will monitor and perform routine compliance checks on all source data in alignment with protocol requirements and in compliance with ICH-GCP, FDA Regulations, and K2 Medical Research SOPs.

This is a hybrid position expected on site 75% of the time, and may work from home the remaining 25% of the time. The position will be required to travel, splitting their time between The Villages and Tampa sites.

Key Responsibilities
  • Review source documents to verify subjects meet Inclusion/Exclusion criteria per protocol requirements to verify eligibility prior to randomization.
  • Review source documents to confirm adherence to organization policies, procedures, and best practices.
  • Create queries for the Project Managers to address missing or incomplete source records or to clarify requirements in the source records.
  • Ensure all queries are responded to and resolved in a timely manner prior to Subject randomization and Sponsor monitoring visits.
  • Work closely with the EDC department to ensure all clinical data entered in respective electronic systems are verified in a timely manner.
  • Communicate compliance trends and reports significant quality issues to the Quality Assurance Department.
  • Assist in the tracking and reporting of compliance trends and metrics.
  • Provide training as needed to Project Managers.
  • Perform ad-hoc projects or other assigned duties on an as-needed basis.
Requirements
  • Bachelor's Degree required; CCRA and/or CCRP preferred.
  • Minimum 3 years of clinical research experience with at least 2 years of patient care experience.
  • Must be willing to travel between The Villages and Tampa facilities.
  • Must be able to work in an office at least 75% of the time.


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