Here at Syneos Health
we are currently recruiting for a Sr Clinical Research Associate I to work with one of the largest and most successful Pharmaceutical companies in the world.
Employment would come from Syneos Health and you would be outsourced to this client.
Job Details :
Identifies, evaluates, and recommends potential investigators / sites on an on-going to assist in the placement of planned clinical studies with qualified investigators.
Critically reviews and analyzes site activities through frequent visits and contacts to monitor study sites following the monitoring plan and applicable Client SOPs, to assure compliance with the protocol, ICH and / or FDA GCP Guidelines and other local regulations.
Ensures quality of data submitted from study sites and assures timely submission of data.
Ensures safety and protection of study subjects according to the monitoring plan, Client SOPs, and ICH and / or FDA GCP Guidelines.
Supervises overall activities of site personnel over whom there is no direct authority and motivates / influences them to meet study objectives.
Anticipates and proactively solves study site problems / issues as they occur. Initiates, recommends and communicates corrective actions as needed.
Ensures documented follow-up to all outstanding issues, within the scope of this position profile.
Appropriately escalates serious or outstanding issues to line manager and project team members.
Proactively communicates and escalates with all internal and external stakeholders any issues identified at study sites while developing the corresponding mitigation strategies and recommended approach.
Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise and objective manner.
What we’re looking for
Minimum of a Bachelor of Science degree in a health related field with min. 4 years clinical research experience
Knowledge of Good Clinical Practice / ICH Guidelines and other applicable regulatory requirements
Must 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 50% on a regular basis
Fluency in Polish and English
Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most.
Learn more about Syneos Health.