Job Summary
The Clinical Research Associate (CRA) plays a pivotal role in the management of clinical trials, ensuring that studies are conducted in compliance with regulatory requirements and protocol specifications. The CRA is responsible for monitoring the progress of clinical trials, verifying that data is collected accurately, and ensuring the safety and integrity of trial subjects.
Responsibilities
- Conduct regular monitoring visits to clinical sites to ensure compliance with study protocols and regulations.
- Review and verify source documents and Case Report Forms (CRFs) for completeness and accuracy.
- Facilitate communication between various stakeholders including investigators, sponsors, and regulatory authorities.
- Assist in training site staff on study protocols and procedures.
- Identify and resolve issues related to study conduct and participant safety.
- Maintain accurate and up-to-date study documentation and records.
Qualifications
- Bachelor’s degree in Life Sciences or a related field.
- Previous experience in clinical research or monitoring is preferred.
- Strong understanding of Good Clinical Practice (GCP) and regulatory requirements.
- Excellent communication and interpersonal skills.
- Ability to work independently and manage multiple tasks effectively.
- Attention to detail and strong organizational skills.
