Hobson Prior are looking for a Clinical Research Associate to join an innovative biotech company who are focused on the development of Oncology products. This role will entail providing monitoring support to the clinical operational team and will be a home working position to be based anywhere in Switzerland, with occasional visits to a site in Basel.
- Accountable for carrying out the duties related to monitoring in compliance with applicable SOPs, international regulations and directions from management.
- With minimal supervision, manage sites participating in complex clinical studies and/or sites requiring more than minimal oversight of operational issues.
- Oversee the overall activities of site personnel and be responsible to motivate and influence them to meet study objectives.
- Conduct all clinical site monitoring activities according to the monitoring plan and in accordance with the study timelines and company objectives.
- Review the ongoing efforts and activities of the company clinical sites, to ensure compliance with the protocol, applicable regulations and ICH Guidelines.
- Responsible for the quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
- Ensure accurate and adequate reporting of all issues related to safety and protection of study subjects and ensure through compliance with the study monitoring plan, companies’ SOPs, ICH Guidelines, and applicable regulations.
- In charge of ongoing training of study site personnel on the protocol and applicable regulatory requirements, in collaboration with pertinent project team members.
- Report and escalate serious or outstanding issues, as defined in the study monitoring plan.
- Facilitating Quality Assurance Audits, as instructed.
- Ensure the regulatory inspection readiness at assigned clinical sites.
- Manage and monitor the logistics associated with the shipment of clinical samples from study patients.
- Pro- active, flexible and able to multi-task.
- Work well in a team and independently.
- Excellent time management and communication skills.
- IT literate (particularly in Word, Excel, PowerPoint and Access).
- Excellent written and verbal English language.
- Capable to work under pressure.
- Clinical related experience, of which at least 2 years must be as a Clinical Research Monitor.
- Knowledge of the Industry/Clinical trial process and drug development.
- Understanding of ICH GCP.
- University degree or equivalent in health sciences, nursing or pharmacy or related field.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.