STATKING Clinical Services Career Site is Hiring a Clinical Data Entry Associate Near Hamilton, OH
Job Summary: Works under general supervision of the Data Management hierarchy as required performing tasks in the conduct of clinical trials. Essential Functions: The following duties represent the principle job duties however they are not all inclusive:
Adheres to implemented Quality Assurance processes
Tracks Case Report Forms (CRF) reception and follows up if there are missing pages until resolutionReviews CRF and other study material to determine data accuracy and completeness and to detect study protocol and data discrepanciesPerforms data entry and/or double-entry verification of CRF into study database Tracks the reporting of adverse events (including serious and non-serious)Issues Data Clarification Forms (DCF) to sites to resolve data discrepanciesAssists in the preparation of packages for the sites/investigators, which may include study documents, the investigational product and other study materials Maintains inventory of study documentsParticipates in department and project audits, if required Additional Responsibilities: Knowledge of:
MS Office
Electronic systems currently in use at JSS Medical Research to process data for clinical trials
Medical Terminology
Requirements of Good Clinical Practices
Requirements of Good Documentation Practices
Requirements of FDA 21 CFR Part 11 for Handling of Electronic Records
Ability to:
Maintain and exhibit discretion at all times when handling confidential information
Research and verify information to ensure accuracy
Enter accurate data as instructed
Communicate effectively orally and in writing
Assume multiple and concurrent tasks and responsibilities
Establish and maintain cooperative and effective working relations with fellow employees
Demonstrate integrity, respect, professionalism, commitment and accountability
Job Qualifications: General Knowledge, Skills, and Abilities (KSA’s) required Experience and Education:
Minimum CEGEP degree or one year relevant experience
Ideally 1 year experience directly related to data entry