Clinical Research Associate
4 weeks ago
Job Overview
At IQVIA, we are seeking a highly skilled Clinical Research Associate to join our team. The successful candidate will provide Trial Master File (TMF) related assistance to study teams, ensuring all work is conducted in accordance with Standard Operating Procedures (SOPs), policies, practices, good clinical practices, applicable regulatory requirements, and meets quality and timeline metrics.
Key Responsibilities
Perform assigned complex administrative tasks to support team members with project execution
Assist in updating and maintaining complex data in systems within project timelines and per project plans
Coordinate the retrieval of records requested by users and prepare closed studies to final destination within agreed timelines
Conduct and manage scanning processes and train staff on scanning processes
Interface with departments to support retrieval projects and ensure information needs are met
Serve as primary contact for internal/external clients
Monitor and review filing accuracy and compliance to IQVIA or customer file plans and Standard Operating Procedures (SOPs) where applicable
Maintain records center security to protect record integrity by ensuring compliance to SOPs
May coordinate transfer, recall, and disposition of records to commercial records storage centers
Oversee disposal of obsolete records and ensure efficient maintenance of records storage space, supplies, and equipment
Train team members on records management tasks, policies, and procedures
Establish and maintain effective internal and external client communications
Design and administer records management systems and processes
Ensure project deadlines, commitments, and goals are met by monitoring projects daily outputs
May function as team leader for records management projects
Requirements
High School Diploma or equivalent required
3-4 years' experience working in a relevant clinical research environment
Good knowledge of applicable clinical research regulatory requirements; i.e., International Conference on Harmonization (ICH), Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines;
Knowledge of technology applications relevant to records center environments
General knowledge of computer technology and software programs, and accurate data entry skills
Attention to detail and accuracy in work
Ability to achieve productivity despite time pressure constraints
Good problem solving skills
Strong organizational, planning, and decision making skills
Good time management and prioritization skills
Extensive knowledge of records management laws and regulations
Excellent oral and written communication skills including good command of English language
Ability to manage and lead others
Ability to establish and maintain effective working relationships with internal and external clients
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