Clinical Data Associate

2 weeks ago

Bloemfontein, South Africa Staff Unlimited Recruitment Pty Ltd TA MPC Recruitment Group EC Full time

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

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