Pharmaceutical Research Associate II Role
2 settimane fa
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.
Job OverviewThe Pharmaceutical Research Associate II role is a key position within Syneos Health, where you will work closely with our clients to deliver high-quality clinical trials. As a Pharmaceutical Research Associate II, you will be responsible for conducting site qualification, site initiation, interim monitoring, site management activities, and close-out visits, ensuring regulatory compliance and adherence to ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) guidelines.
Responsibilities- Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits, ensuring regulatory compliance and adherence to ICH-GCP and/or GPP guidelines.
- Evaluate overall performance of site and site staff, providing recommendations regarding site-specific actions, and immediately communicate/escalate serious issues to the project team.
- Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
You will also verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Additionally, you will demonstrate diligence in protecting the confidentiality of each subject/patient, assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site, and identify protocol deviations/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.
- 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.
The estimated salary for this role is $60,000 - $80,000 per year, based on location and industry standards. Syneos Health offers a competitive compensation package, including medical, dental, and vision insurance, 401(k) matching, and paid time off. We are committed to diversity and inclusion and strive to create a workplace that reflects the communities we serve.
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