Clinical Research Associate I(FSP)
4 weeks ago
Parexel's Clinical Research Associate I(FSP) Role
As a Clinical Research Associate I(FSP) at Parexel, you will play a critical role in the success of our clinical trials. Your primary responsibility will be to ensure the smooth execution of studies at investigator sites, ensuring that all regulatory requirements are met and that data quality is maintained.
Key Responsibilities:
- Source Data Verification (SDV) and Data Management: Conduct SDV and ensure that clinical trials data are submitted to data management in a timely fashion.
- Issue Identification and Closure: Identify issues that may impact the conduct of the study and ensure appropriate closure of all issues.
- Site Management: Proactively manage a greater investigator site workload, ensuring that studies are run efficiently and key study objectives are met.
- Regulatory Compliance: Ensure that studies are run in line with ICH/GCP, local laws, and Client Standard Operating Procedures (SOPs) and procedures.
- Patient Safety: Ensure patient safety is maintained and all safety issues are reported correctly according to all relevant local and international regulatory requirements.
- Communication and Training: Inform the Principal Investigator (PI) and site staff of all issues, agree and develop corrective and preventative actions with PI and site personnel, and train site staff on the protocol, protocol amendments, and Client processes.
- Product and Protocol Knowledge: Understand the product, the protocol, and the therapy area in sufficient detail to be able to have appropriate discussions with the investigator team.
Requirements:
- Interpersonal Skills: Interact with health care professionals in a manner that enhances Parexel's credibility with the customer.
- Data Quality: Ensure that data monitored meets target quality standards and that data is entered into Client systems in a timely manner.
- Reporting and Issue Management: Report on progress of all studies at the investigational site, ensure that all issues are correctly identified and catalogued, and proactively manage issues to appropriate closure.
- Documentation and Record-Keeping: Obtain critical information to enable generation of Investigator Initiation Package (IIP) documentation, assist Clinical Trial Assistant (CTA) in gathering IIP documentation, maintain the Site Master File (SMF) and SMF log, and ensure Electronic Library and Records Archive (ELARA) and/or Client Trial Master File (TMF) is complete and accurate.
- Training and Compliance: Comply with required training curriculum, complete timesheets accurately, submit expense reports as required, update CV as required, and maintain a working knowledge of and comply with Parexel processes, ICH-GCPs, and other applicable requirements.
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