Research Coordinator Jobs

About The Position

Requirements

• High School Diploma or GED.
• Minimum of 2 years of clinical research-related experience.

Nice To Haves

• Bachelor's Degree in Science, Sociology, or a related field.
• SOCRA or ACRP certification.

Responsibilities

• Independently coordinate studies, including screening potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process.
• Schedule patients for research visits and procedures.
• In collaboration with physicians and other medical personnel, document patient condition changes, adverse events, concomitant medication use, protocol compliance, and response to study drug on Case Report Forms (CRFs).
• Maintain accurate source documents related to research procedures.
• Perform accurate and timely data collection, documentation, entry, and reporting, including timely responses to sponsor queries.
• Schedule and participate in monitoring and auditing activities.
• Compile and report information for each study, including protocol activity, accrual data, workload, and other research information, and present it at regular research staff meetings.
• Notify the direct supervisor of concerns regarding data quality and study conduct.
• Work with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
• May perform other regulatory or IRB duties, budgeting duties, and assist with patient research billing and reconciliation.
• Ensure compliance with federal and local agencies and requirements, including the Food and Drug Administration (FDA) and local IRB.
• Maintain research practices in accordance with Good Clinical Practice (GCP) guidelines.
• Maintain strict patient confidentiality according to HIPAA regulations and applicable law.
• May coordinate training and education of other personnel.
• May participate in centralized activities such as auditing and Standard Operating Procedure development.
• May plan and coordinate strategies to increase patient enrollment or improve clinical research efficiency.
• May identify quality and performance improvement opportunities and collaborate with staff to develop action plans.
• May identify new research opportunities and present them to investigators.
• Participate in required training and education programs.