Clinical Research Associate

Job Type- Fresher or Internship level

Clinical Research Associates manage clinical trials and studies pertaining to biotechnological and pharmaceutical products, drugs and procedures. A Clinical Research Associate, also known as a CRA, conducts research to ensure these products are safe.

Responsibilities:

1. Assist in Protocol Development:

• Collaborate with the clinical research team to contribute to the development and review of clinical trial protocols.

2. Site Identification and Selection:

• Participate in the process of identifying and selecting clinical trial sites by conducting feasibility assessments.

3. Regulatory Compliance:

• Support the team in ensuring regulatory compliance throughout the clinical trial process.
• Assist in the preparation and submission of regulatory documents to appropriate health authorities.

4. Site Initiation:

• Assist in the initiation of clinical trial sites by coordinating site training activities and ensuring that all necessary documentation is in place.

5. Monitoring and Data Collection:

• Work closely with clinical research associates and investigators to monitor and collect data during the clinical trial.
• Assist in ensuring data accuracy, completeness, and adherence to protocol.

6. Adverse Event Reporting:

• Contribute to the process of monitoring and reporting adverse events, ensuring compliance with regulatory requirements.

7. Study Close-Out:

• Participate in the close-out activities of clinical trials, including the collection of essential documents and finalizing study reports.

8. Collaboration and Communication:

• Work collaboratively with cross-functional teams, including clinical operations, data management, and regulatory affairs.
• Communicate effectively with investigators, site staff, and study sponsors.

9. Documentation and Record Keeping:

• Maintain accurate and up-to-date documentation of all activities performed during the internship.
• Contribute to the development and organization of the trial master file.

10. Learning and Development:

• Actively engage in learning opportunities provided during the internship to enhance knowledge of clinical research processes and industry regulations.

Qualifications:

• Currently enrolled in a Bachelor's or Master's degree program in a related field (e.g., Life Sciences, Pharmacy, Nursing, etc.).
• Excellent communication and interpersonal skills.
• Detail-oriented with strong organizational and time management abilities.
• Ability to work independently and as part of a team.