Job Summary
The Clinical Research Associate II plays a vital role in overseeing clinical trials and ensuring they are conducted in accordance with regulatory standards and protocols. This position is essential for the management and monitoring of clinical research, contributing to the advancement of medical knowledge and patient care.
Responsibilities
- Monitor clinical trial sites and ensure compliance with Good Clinical Practice (GCP) guidelines.
- Conduct site initiation, monitoring, and close-out visits.
- Review and evaluate study-related documents, including informed consent forms and case report forms.
- Maintain accurate records of trial progress and site activities.
- Facilitate communication between the sponsor and clinical sites.
- Assist in the training and onboarding of new clinical staff.
- Identify and resolve issues relating to trial execution and data collection.
Qualifications
- Bachelor’s degree in life sciences or a related field.
- A minimum of two years of experience in clinical research.
- Strong understanding of regulatory requirements and clinical research processes.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a collaborative team.
- Proficiency in data management and relevant software.
