Job Title: Clinical Research Associate
Location: Bengaluru, India
Company: Parexel
Job Overview:
As a Clinical Research Associate (CRA) at Parexel, you will play a crucial role in ensuring the safety and well-being of patients while contributing to clinical research. You will be responsible for monitoring investigator sites, ensuring study compliance, and maintaining data integrity throughout the clinical trial process.
Key Responsibilities:
Study Maintenance (Initiation to Close-out):
Act as the primary contact for assigned sites, ensuring protocol adherence and resolving site-related issues.
Build and maintain relationships with investigators and site staff.
Support sites with study system access and compliance with training requirements.
Assess site staff assignments and implement corrective actions if needed.
Identify and resolve documentation issues and compliance deficiencies.
Address site-related questions and ensure resolution of pending issues from previous visits.
Conduct literature reviews and data analysis to maintain study integrity.
Participate in investigator meetings, audits, and regulatory inspections as required.
Review, approve, and maintain site documentation, including regulatory compliance.
Evaluate and improve site recruitment plans in collaboration with site staff.
Conduct site visits, including qualification and initiation visits, and generate visit reports.
Assess and manage study supplies, including test article accountability and returns.
Ensure timely CRF data entry, query resolution, and SAE follow-ups.
Conduct study-specific training and site facility assessments.
Monitor compliance and performance of sites and recommend corrective actions.
General Responsibilities:
Ensure timely and accurate completion of project goals.
Update trial management systems and monitor site-level data compliance.
Ensure all study sites are audit- and inspection-ready.
Maintain compliance with ICH-GCP and applicable international and local regulations.
Delegate and review administrative tasks as needed.
Maintain a positive and results-oriented work environment.
Provide input for performance development and proactively communicate work progress.
Develop expertise to become a subject matter expert in clinical research.
Required Skills:
Strong problem-solving skills and ability to work independently.
Advanced presentation and communication skills.
Client-focused approach and ability to interact professionally with stakeholders.
Ability to manage multiple tasks while maintaining accuracy and attention to detail.
Strong time management and analytical skills.
Proficiency in Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS), and Microsoft Office.
Willingness to work in a team environment with a flexible attitude toward assignments.
Ability to accommodate extensive travel requirements and possess a valid driver's license if required.
Qualifications & Experience:
Degree in biological sciences, pharmacy, or a health-related discipline preferred, or an equivalent nursing qualification.
Previous site management or equivalent experience in clinical research.
Understanding of clinical trial methodologies and regulatory requirements.
Application Link: [Insert application link here]
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