Clinical Research Associate
4 weeks ago
Job Overview
Performing Site Monitoring and Management Tasks: As a Clinical Research Associate, you will be responsible for ensuring that study sites are conducting the required research activities in accordance with contracted scope of work, regulatory requirements, and sponsor expectations.
Key Responsibilities:
- Conduct site monitoring visits to ensure compliance with Good Clinical Practice (GCP) guidelines and International Conference on Harmonization (ICH) regulations.
- Work closely with study sites to adapt, drive, and track subject recruitment plans, enhancing predictability and project outcomes.
- Deliver protocol and related study training to assigned sites, fostering regular communication and issue resolution.
- Evaluate study site practices, identifying quality issues, and escalating them as necessary.
- Manage study progress by tracking regulatory submissions, recruitment, case report form completion, data query generation, and resolution.
- Maintain accurate documentation, including site management records, visit reports, and follow-up letters, in accordance with GCP and local regulatory requirements.
- Collaborate with study team members to support project execution and address site-specific needs.
Qualifications and Skills:
- Bachelor's Degree in a scientific discipline or healthcare preferred; at least 1 year of on-site monitoring experience is required.
- Familiarity with applicable clinical research regulatory requirements, including GCP and ICH guidelines.
- Therapeutic and protocol knowledge, as provided through company training.
- Proficiency in using Microsoft Office applications, particularly Word, Excel, and PowerPoint, and a laptop computer.
- Excellent written and verbal communication skills, with a good command of the English language.
- Strong organizational, problem-solving, time, and financial management skills.
Salary Information: The estimated annual salary for this position ranges from $80,000 to $120,000, depending on location and qualifications. This figure includes an average base salary of approximately $95,000, plus benefits and bonuses.
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