Site Visit Report Reviewer Job at Parexel

Job Description

The Site Visit Report Reviewer (SVRR) is responsible for reviewing site qualification, site initiation, monitoring, and termination visit reports, ensuring they meet quality standards, regulatory requirements, Parexel Standard Operating Procedure (SOP), International Conference on Harmonization/ Good Clinical Practice (ICH/ GCP) guidelines, and protocol requirements. Working in close collaboration with Clinical Research Associates (CRAs), Clinical Operations Leaders (COLs), and project teams, the SVRR diligently monitors the progress of Open Issues, Protocol Deviations (PDs), and ongoing Serious Adverse Events (SAEs) as documented in Monitoring Visit Reports (MVRs), following up until closure. Additionally, the SVRR may participate in project meetings as needed, conducts and communicates periodic analyses of monitoring visits and issues to project teams, and assists the COL with additional tasks as required, contingent upon successful completion of appropriate training.

Job Responsibility

Reviewing site qualification, site initiation, monitoring, and termination visit reports, ensuring they meet quality standards, regulatory requirements, Parexel Standard Operating Procedure (SOP), International Conference on Harmonization/ Good Clinical Practice (ICH/ GCP) guidelines, and protocol requirements
Working in close collaboration with Clinical Research Associates (CRAs), Clinical Operations Leaders (COLs), and project teams, the SVRR diligently monitors the progress of Open Issues, Protocol Deviations (PDs), and ongoing Serious Adverse Events (SAEs) as documented in Monitoring Visit Reports (MVRs), following up until closure
Participating in project meetings as needed
Conducting and communicating periodic analyses of monitoring visits and issues to project teams
Assisting the COL with additional tasks as required

Requirements

Excellent interpersonal, verbal and written communication skills.
Flexible and positive attitude towards work assignments and new learning.
Ability to manage multiple tasks, prioritize workload, and maintain attention to detail while committing to high-quality work.
Willingness to work in a complex environment and value teamwork.
Client-focused approach to work.
Initiative to work independently and seek guidance when necessary.
Strong analytical and decision-making skills.
Proficient in computer skills, including Microsoft Office products.
Manage time effectively and demonstrate a sense of urgency in completing tasks.
Ability to work across cultures.
Successful work in a ('virtual') team environment and maintaining consistent performance.
Proactive issue identification and effective problem-solving skills.
Knowledge of and compliance with ICH-GCP Guidelines, regulations, and Parexel/Client procedures.
Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.
Educated to degree level (biological science, pharmacy or other health-related discipline preferred), nursing or other relevant qualification/experience

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Site Visit Report Reviewer

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