Clinical Research Associate
7 days ago
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:
Assist in Protocol Development:
Collaborate with the clinical research team to contribute to the development and review of clinical trial protocols.
Site Identification and Selection:
Participate in the process of identifying and selecting clinical trial sites by conducting feasibility assessments.
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.
Site Initiation:
Assist in the initiation of clinical trial sites by coordinating site training activities and ensuring that all necessary documentation is in place.
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.
Adverse Event Reporting:
Contribute to the process of monitoring and reporting adverse events, ensuring compliance with regulatory requirements.
Study Close-Out:
Participate in the close-out activities of clinical trials, including the collection of essential documents and finalizing study reports.
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.
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.
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.
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