Here at Syneos Health we are currently recruiting for a Clinical Research Associate II to join our General Medicine team in Poland.
- 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 BMS 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, BMS 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.
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- Minimum 2 years` of experience in independent monitoring
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Experience in monitoring dermatology studies will be an asset
- 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
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.