Clinical Research Coordinator

About the Role

Responsible for assisting with coordinating clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies.

Key Responsibilities

• Assists with coordinating all aspects of patient involvement from study initiation until study completion.
• Organizes research information for clinical trials.
• Observes subjects and assists with data analysis and reporting.
• Schedules the collection of data.
• Documents adverse events, protocol deviations, and other unanticipated problems appropriately.
• Reports research data to maintain quality and compliance.
• Performs administrative and regulatory duties related to the study as appropriate.
• Participates in other protocol development activities.
• Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.).
• Educates potential participants and caregivers on protocol specific details and expectations.
• Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned).
• Assumes other duties and responsibilities as assigned.

Requirements & Tech Stack

• High school graduate or equivalent; Bachelors Degree, preferred.
• 0-3 years of experience in the medical field.
• Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials.
• Strong leadership and mentorship skills.
• Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level.
• Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations.
• Works independently as well as functioning as part of a team.
• Must be able to effectively communicate verbally and in writing.

Working Conditions

• Indoor, Office environment.
• Shift work, depending on location.
• Essential physical requirements include sitting, typing, standing, and walking.
• Lightly active position, occasional lifting of up to 20 pounds. Rarely lift over 20 pounds.
• Reporting to work, as scheduled, is essential.
• Overnight travel may be required for training and/or investigative meetings.