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Clinical Research Associate
1 mese fa
As a Senior Clinical Research Associate at Syneos Health, you will play a critical role in the success of our clinical trials. You will be responsible for performing site qualification, site initiation, interim monitoring, site management, and close-out visits, ensuring regulatory, ICH-GCP, and protocol compliance. You will use your judgment and experience to evaluate the overall performance of sites and site staff, providing recommendations for site-specific actions. You will also maintain a working knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.
Key Responsibilities
* Performs site qualification, site initiation, interim monitoring, site management, and close-out visits, ensuring regulatory, ICH-GCP, and protocol compliance.
* Evaluates the overall performance of sites and site staff, providing recommendations for site-specific actions.
* Maintains a working knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.
* Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
* Demonstrates diligence in protecting the confidentiality of each subject/patient.
* Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
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.
* Ability to manage required travel of up to 75% on a regular basis.
About Syneos Health
At Syneos Health, we are passionate about developing our people, through career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program. We are committed to our Total Self culture, where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives, we're able to create a place where everyone feels like they belong.
