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Form of work
SalaryPosition Description:
Under the direction and supervision of the Director of Data Management, this position is responsible for performing all Data Entry functions as they relate to the completion of case report forms, by entering study data collected by the research team into the Electronic Data Capture (EDC) system. Data entry personnel will also resolve all data queries. The position works closely with the research coordinators in support of all ongoing clinical studies.
PRINCIPAL DUTIES AND ESSENTIAL FUNCTIONS:
- Oversee and manage the Data Entry from the source document to the case report form (CRF)
- Reviews patient records for completeness and accuracy
- Coordinates and schedules monitor(s) visits.
- Meets with sponsor/monitors to review Data Entry. Provides support and information to monitors as necessary and as directed by supervisor(s).
- Timely resolution of data queries promptly to insure completeness of CRFs.
- Complies with all applicable regulations, guidelines and procedures pertaining to data loading, EDC and clinical research
- Identifies lab facilities used for studies so that lab certifications can be requested for study files.
- Assures that Data Entry remains current for all studies per SOP.
- Reviews and utilizes protocols as guides for study activities.
- Communicates as needed with accounts receivable staff regarding submitted data.
- Attends meetings and briefings regarding clinical studies as required.
- Ability to assist in the guidance and training of less experienced staff.
- Ability to maintain a positive attitude with the research team.
- Maintain professional demeanor with sponsors, monitors and auditors.
- Remains current with all required training.
- Performs other duties as assigned.
KNOWLEDGE AND SKILLS:
- 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.
- Excellent organizational skills to independently manage work flow.
- Ability to prioritize quickly and appropriately with minimal guidance.
- Ability to multi-task.
- Ability to work independently and function as part of a team.
- Ability to react calmly in emergent situations.
- Clear and concise verbal and written communications.
