Clinical Research Associate II for Syneos Health
hace 7 horas
Clinical Research Associate II Job Description
Syneos Health, a leading biopharmaceutical solutions organization, is seeking a Clinical Research Associate II to accelerate customer success.
We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and patient to the center of everything we do.
We are continuously looking for ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for.
As a Clinical Research Associate II, you will collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.
We are agile and driven to accelerate the delivery of therapies because we are passionate about changing lives.
Why 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 programs.
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.
Key Responsibilities
- Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP, and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
- Use judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the project team and develop action plans.
- Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
Qualifications
- 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.
- Demonstrate good computer skills and be able to embrace new technologies.
- Excellent communication, presentation, and interpersonal skills.
- Ability to manage required travel of up to 75% on a regular basis.
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