Clinical Research Coordinator

Gastroenterology Consultants of Savannah

Job Description

The Clinical Research Coordinator (CRC) is responsible for managing clinical trial performance, including study participant enrollment, study-specific documentation, and study-related training, at a GI group located in Birmingham, Alabama, with two to three close proximity satellite offices.

Primary Responsibilities

· Coordinate a clinical trial (e.g., blood draw/biomarker study) conducted by a supervising PI in accordance with FDA, GCP and protocol guidelines, including:

· screening participants

· obtaining informed consent

· coordinating visits and procedures

· managing lab kits

· collecting and documenting data ( study records, including regulatory forms, drug accountability records, and progress reports)

· reporting any adverse events

· Identify study-related issues, potential problems, or inconsistencies, and take action as appropriate.

· Review all study protocols and train applicable personnel at each assigned site.

· Communicate study, or protocol, issues to the CRO and/or Sponsor, Site Lead, Manager, Principal or Sub-Investigator and other members of the study team, as applicable.

· Ensure data collected for the study is accurate, attributable, and contemporaneous

· Maintain timely EDC data entry and query resolution.

· Complete all queries in a timely manner

· Attend conference calls for the company or Sponsor as needed

· Perform other study-related duties as assigned.

· Ensure that the company and the sites are adhering to all applicable federal and/or local regulatory standards.

Requirements:

• Minimum 3 years as a Clinical Research Coordinator
• Regulatory Documentation knowledge
• GCP certification
• Proficient in Phlebotomy
• IATA certification (may be forthcoming)
• Excellent written and oral communication skills
• Ability to multi-task and handle consistent workflow.
• Computer, email and MS Office competence
• Proficient with medical terminology

A team player who is detail-oriented