Job Summary

A clinical research coordinator is a key figure in clinical research projects, responsible for overseeing and managing various aspects of clinical trials and studies. Their primary role is to ensure that research protocols are implemented efficiently, ethically, and in compliance with regulatory requirements.

Key Responsibilities

• Coordinate participant study visit
• Prepare charts and supplies for study visits
• Lead participant tests, procedures, and eDiary set up
• Data entry for study visits
• Maintain participant charts
• Send participant reminders for eDiary completion, fasting visits, etc.
• Attend SIV/IM for primary studies
• Study monitor interactions for site specific and/or patient issues
• Assist study monitors during scheduled IMV/COV
• Remote monitor interactions when needed
• Manage investigational product supplies for primary studies
• Dispense investigation product or study medication to participants
• Answer queries for primary studies as needed
• Complete necessary trainings
• Keep ISF logs updated for primary studies
• Point of contact for patient related escalations/issues (e.g. AE, SAE, compliance issues, eligibility concerns, unblinding)
• Review medical records with investigator when received to ensure all study criteria are met
• Attend and contribute to weekly CRC meetings
• Attend and contribute to quarterly staff meetings
• Perform additional duties and projects as assigned

Qualifications

• Previous laboratory or clinical research experience preferred
• Excellent organizational skills and ability to work in a fast-paced environment
• Calm under pressure and capable of solving sudden problems that may not have clear answers or readily available resources
• Proficient in navigating unfamiliar technology and programs independently and adeptly such as site CTMS
• Personable
• Effective communicator who can cooperate as a member of a team
• Ability to prioritize, multitask and work independently within a hierarchy
• Proficient with Microsoft Office 365 suite

Education and Experience

• Bachelor’s degree or higher or equivalent clinical research experience preferred