Clinical Research Coordinator

Benefits

Qualifications

• •Minimum 2 years of experience in a clinical research environment
• •Must have a working knowledge and be skilled in the use of personal computers, information storage and retrieval systems
• •Candidates must be highly organized, utilize excellent verbal and written communication and able to multi-task
• •UNIQUE PHYSICAL/MENTAL DEMANDS, ENVIRONMENT, AND WORKING CONDITIONS:
• •Minimum 2 years of experience in a clinical research environment
• •Must have a working knowledge and be skilled in the use of personal computers, information storage and retrieval systems
• •Candidates must be highly organized, utilize excellent verbal and written communication and able to multi-task
• •4 more items(s)

Responsibilities

• •TITLE: Clinical Research Coordinator
• •JOB OVERVIEW: Clinical Research Coordinators manage clinical studies and site personnel from pre-study planning to successful completion
• •Clinical Research Coordinator responsibilities include but are not limited to:
• •Participates in evaluation of new protocols
• •Maintains/updates all SOP's and supporting procedures
• •Pre-screening, screening, recruiting and enrolling patients
• •Scheduling and retaining patients
• •Administer diagnostic tests as required by sponsor protocol
• •Data collection and documentation
• •Collecting and recording adverse events and concomitant medications
• •Processing Serious Adverse Events
• •Study drug administration and accountability
• •All data entry, whether electronic data capture or on paper
• •Schedule monitor visits, meet with monitors, etc,
• •Develops and maintains a system for processing/tracking/filing all protocol-related regulatory documentation and study contracts/budgets
• •Attend investigator meetings
• •Source document development
• •Prepares/completes/complies all forms and documentation for IRB and sponsor submissions, annual reviews, amendments and study closure
• •Tracking/submission/filing of all safety reports/adverse events/protocol deviations to sponsors/CROs/IRBs
• •Fulfill all reporting obligations to sponsors and CROs
• •Ensures center activities are in compliance with federal regulations, Good Clinical Practice guideline and center policies
• •Management of all miscellaneous tasks involved with coordinating clinical trials
• •Obtain IATA certification
• •Conducts in-service/ training for center staff as needed
• •Performs other related job duties as required
• •22 more items(s)