Clinical Site Monitor II (CRA II)
•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.
The ideal candidate will need the following experience / skills to be considered:
- Minimum of a Bachelor of Science degree in a health related field with around 1,5 or 2 years clinical research experience
- Previous proven experience in monitoring Oncology studies.
- Demonstrated success in working independently
- Strong communication and leadership skills
- Ability to work independently and travel up to 50% of time.
- Fluent in Polish and English.