Clinical Research Associate

Job Titles:: CRA I/ CRA II/Senior CRA Locations:: Any metro location in India Therapeutic Area Experience:: Any biopharmaceutical and minimum 2 years of on site monitoring experience Job Overview: Perform monitoring and site management to ensure compliance with study protocols, regulations, guidelines, and sponsor requirements. Essential Functions:

• Conduct site monitoring visits (selection, initiation, monitoring, and close-out) per GCP and ICH guidelines.
• Adapt, drive, and track subject recruitment plans to meet project needs.
• Provide protocol and study training to sites and maintain regular communication.
• Evaluate site practices for protocol adherence and escalate quality issues.
• Track study progress, including regulatory submissions, recruitment, CRF completion, and data queries.
• Ensure site documents are filed in the Trial Master File (TMF) and Investigator's Site File (ISF) per GCP/ICH and local regulations.
• Document site management, visit findings, and action plans through reports and follow-up letters.
• Collaborate with study team members for project support.
• Support development of project subject recruitment plans and site financial management as needed.

• Bachelor's degree in a scientific discipline or healthcare preferred.
• Equivalent education, training, and experience may be accepted.
• Completion of CRA training program or prior monitoring experience preferred.
• Basic knowledge of clinical research regulatory requirements (GCP and ICH guidelines).
• Proficiency in Microsoft Word, Excel, PowerPoint, and use of laptops and mobile devices.
• Strong written and verbal communication skills in English.
• Excellent organizational, problem-solving, and time management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.