Senior Clinical Research Associate
Há 1 mês
As a Senior Clinical Research Associate at Syneos Health, you will be responsible for ensuring the successful conduct of clinical trials at investigator sites. This includes site qualification, initiation, monitoring, and close-out visits. You will verify the process of obtaining informed consent and ensure regulatory compliance with ICH-GCP and local regulations. Additionally, you will maintain a working knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.
Key Responsibilities:\
- Perform site qualification, initiation, interim monitoring, site management, and close-out visits to ensure regulatory compliance.
- Verify the process of obtaining informed consent and ensure accuracy of clinical data.
- Maintain a working knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.
- Assess site processes and apply query resolution techniques remotely and on-site.
- Utilize available hardware and software to support the effective conduct of clinical study data review and capture.
Requirements:\
- Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Excellent communication, presentation, and interpersonal skills.
- Able to manage required travel of up to 75% on a regular basis.
At Syneos Health, we are dedicated to building a diverse, inclusive, and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. Discover what our 29,000 employees already know: work here matters everywhere.
", "Qualifications": "What we're looking for:
- Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Excellent communication, presentation, and interpersonal skills.
- Able to manage required travel of up to 75% on a regular basis.
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.
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