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Clinical Study Manager

2 months ago

Hinesville, Georgia, United States BVL Clinical Research Institute Full time
Job Description

Company Overview

BVL Clinical Research Institute, LLC is a leading clinical research site specializing in gastroenterology and inflammatory bowel disease research.

Job Summary

We are seeking a highly skilled Clinical Research Coordinator to support the conduct of clinical trials. The successful candidate will work closely with the Principal Investigator and research team to ensure the smooth execution of study protocols.

Key Responsibilities

  • Study Protocol Management
    • Explain study protocols, procedures, and treatments to patients and families
    • Conduct the Informed Consent process in conjunction with study investigators
  • Regulatory Compliance
    • Ensure that all protocol activities are performed by approved research staff and ensure protocol compliance
    • Assess and report adverse study events, including to the IRB and any research sponsors
  • Study Operations
    • Prepare laboratory specimens for analysis, monitoring tests and procedures, ship frozen specimens
    • Manage conduct of experimental tests and procedures
    • Handle all data and source documentation, adverse experience reporting, and maintenance of complete regulatory files
  • Communication and Collaboration
    • Screen, enroll, and perform follow-up of study subjects
    • Review specific job responsibilities with Principal Investigator (PI) for each protocol
    • Assist in assessing feasibility of clinical trials
  • Quality Assurance
    • Implement and maintain periodic quality control procedures
    • Maintain all regulatory documents
  • Reporting and Documentation
    • Prepare research reports
    • Participate in any internal and external audits or reviews of study protocols
  • Professional Development
    • Acquire continuing education pertinent to research and their licensed profession

Requirements

The ideal candidate will possess a strong understanding of clinical research principles and practices, excellent communication and organizational skills, and the ability to work effectively in a fast-paced environment.

Salary and Benefits

Salary based on experience.