clinical research associate.

The Clinical Research Associate (CRA) plays a fundamental role in the drug development process.   You will be responsible for overseeing the progress of clinical trials and ensuring they are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements.

 

Key Responsibilities

• Site Management:Serve as the primary point of contact for investigative sites.   Build and maintain strong relationships with investigators and site staff.
• Monitoring Visits:Conduct the full lifecycle of site visits, including:
• Pre-study Visits (PSV):Assessing site facilities and personnel.
• Site Initiation Visits (SIV):Training site staff on protocol and procedures.
• Routine Monitoring Visits (RMV):Verifying Source Data Verification (SDV) and ensuring protocol compliance.
• Close-out Visits (COV):Ensuring all trial activities are finalized and documented.
• Data Integrity:Perform 100% source document verification to ensure the accuracy, completeness, and verifiability of Case Report Forms (CRFs).
• Regulatory Compliance:Ensure all Essential Documents are filed in the Trial Master File (TMF) or Investigator Site File (ISF).   Assist sites in preparing for audits and inspections.
• Safety Reporting:Verify that all Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported within the required timelines.
• Drug Accountability:Monitor the storage, dispensing, and return of Investigational Products (IP).

 

Qualifications & Requirements

• Education:Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related field.
• Experience:Minimum of 3 years of independent field monitoring experience in a CRO or Pharmaceutical company.
• Knowledge:Deep understanding of ICH-GCP guidelines and local regulatory requirements (e.g., FDA, EMA, or NMPA).

Skills

• Proficiency in Clinical Trial Management Systems (CTMS) and Electronic Data Capture (EDC) platforms.
• Excellent written and verbal communication skills in English.
• Strong organizational skills with the ability to manage multiple sites simultaneously.