Position Overview
Our client, a specialized CRO is seeking a Clinical Data Associate to join their team, who will be responsible for maintaining and constantly improving performance and quality in data management services. This includes but is not limited to the following activities: Database set-up, CRF tracking, review, validation and updating data in clinical databases for paper and EDC studies and assisting in development of data management-relevant study documents. Responsibilities also include supporting other (data management) team members
Essential Job Functions
- CRF Tracking and scanning including set-up and testing of tracking database
- Data Entry support where required and Verification of data entry discrepancies and creation data entry guideline
- Support in database set-up activities for paper and EDC studies such as creation of a CRF, set-up and testing of study databases, creation of test cases for data entry screens and plausibility checks
- Validation of CRF, Query and external data
- Creation and management of queries related to CRF or external data
- External data reconciliation
- Support in quality control tasks for CRF data
- Participation in team and project meetings
- Support in TMF related activities
- Preparation of data management TMF parts for archiving
- Support of Clinical Data Managers
- Process improvements
Optional/Developmental Job Functions
- SAE reconciliation
- User account management
- User training and related activities for EDC studies
- Creation and maintenance of external and internal training documentation for EDC studies (general and project specific)
- Support of eClinical Project Manager
Requirements
- Education or experience in the field of medical documentation or a related field
- Knowledge in GCP requirements and understanding of regulatory guidelines in drug research.
- Good computer skills and proficiency with data management software, MS Word, Excel and the Internet
- Problem solving skills and ability to work both independently and in teams
Other Skills/Abilities
- Sound communication skills – interpersonal and both verbal and written in English
- A flexible attitude with respect to work assignments and new learning
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
