Clinical Research Coordinator - 257298

Responsibilities

Key duties include but not limited to:

• Responsible for the integrity and overall quality of assigned clinical research trials
• Serves as the primary contact for study subjects and sponsors, communicating daily as needed.
• Reviews study protocols and brochures; creates study document binder and prepares source documents including study and subject information folders.
• Attend sponsor meeting as needed for assigned protocols.
• Oversee sponsor database process.
• Completes study procedures including:
• Pre-screening, screening, and study visits in conjunction with Physician/Investigator (may include vital signs, performing EKG’s, phlebotomy, processing specimens and shipping to labs).
• Documentation of patient progress in response to investigative agents.
• Coordination of monitor visits with patients.
• Completion of source documents and case report forms.
• Oversee preparation of physician orders to ensure protocol compliance as needed.
• Maintain communication with physician regarding study requirements, dose modifications, and adverse events.
• Upkeeps all trial regulator documentation.
• Maintain high level of understanding of the ICH/GCP guidelines.
• Perform other related duties as assigned

Qualifications

• A minimum of 2 year's relevant work experience as a Clinical Research Coordinator.
• This person must be highly detailed oriented, possess stellar organizational and prioritization skills, have excellent verbal and written communication and can work in a fast paced environment under limited supervision.
• Skilled with Electronic Medical Record (EMR

Preferred:

• At least 2 years of experience as a Clinical Research Coordinator or similar role; Neurology experience a strong plus. CCRC certified a strong plus
• Prior working knowledge of research methodology, medical terminology and pharmacology.)