Monitor Liaison - DFW

Job Description

Qualifications

• •Working knowledge of clinical research Electronic Data Capture (EDC) systems
• •Excellent interpersonal skills to deal effectively with research personnel
• •Knowledge of medical terminology
• •Knowledge of ICH GCP, FDA, OHRP, OSHA and HIPAA guidelines pertaining to clinical research

Benefits

Responsibilities

• •Position Description: Under the direction and supervision of the Director of Data Management, this position is responsible for coordinating, scheduling and managing all monitoring visits
• •The position works closely with the Data Entry Specialists (DES) and serves as their backup for data entry in support of all ongoing clinical studies
• •Coordinates, schedules, and prepares rooms for all monitoring visits
• •Responsible for escorting monitor(s) to all required appointments during their onsite visits
• •Provides support and information to onsite and remote monitors as necessary and as directed by supervisor(s)
• •Serves as a backup to the assigned Data Entry Specialist (DES) to help manage the data entry from the source document to the case report form (CRF)
• •Meets with sponsor/monitors to review data entry as required
• •Complies with all applicable regulations, guidelines and procedures pertaining to data loading, EDC and clinical research
• •Communicates as needed with accounts receivable staff regarding submitted data
• •Attends meetings and briefings regarding clinical studies as required
• •Aides in identifying lab facilities used for studies so that lab certifications can be requested for study files
• •Aides in contacting lab facilities to request lab certifications
• •Ability to maintain a positive attitude with the research team
• •Maintain professional demeanor with sponsors, monitors and auditors
• •Remains current with all required training
• •Assists as needed with the maintenance of medical records
• •Performs other duties as assigned