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.

• 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.