Clinical Operations Specialist
2 days ago
About the Role
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built 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 the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
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.
The ideal candidate will have strong clinical monitoring experience, with a focus on site qualification, initiation, interim monitoring, site management and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
Responsibilities
- Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely)
- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, 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
- 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
- Strong clinical monitoring experience
- Ability to quickly adapt to changing priorities to achieve goals/targets
- Familiarity with electronic data capture requirements
- Knowledge of local requirements for real world late phase study designs
What We Offer
- A competitive salary range of $80,600 to $145,000 annually
- Ongoing training and professional development opportunities
- A dynamic and collaborative work environment
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