Clinical Research Associate
2 giorni fa
Join Syneos Health, a leading biopharmaceutical solutions organization, as a Senior Clinical Research Associate. In this role, you will be responsible for ensuring the successful execution of clinical trials, collaborating with cross-functional teams, and driving site management activities.
Key Responsibilities:- Perform site qualification, site initiation, interim monitoring, site management, and close-out visits to ensure regulatory compliance and protocol adherence.
- Verify informed consent processes and assess site processes, conduct source document reviews, and verify clinical data accuracy.
- Collaborate with site staff to resolve queries and ensure timely completion of study activities.
- May perform investigational product inventory, reconciliation, and reviews, as well as verify IP dispensing and administration.
- Document activities, support subject/patient recruitment and retention, and enter data into tracking systems.
- Understand project scope, budgets, and timelines, and manage site-level activities to ensure project objectives are met.
- 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.
- Ability 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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