Clinical Research Associate II - German Speaking - Switzerland
Proclinical are recruiting for a Clinical Research Associate (CRA II) - German Speaking - Switzerland
to join a CRO. This role is on a permanent basis with the ability to work remotely from anywhere in Switzerland.
- Accountable for assisting with various studies concurrently.
- Support in preparing project specific materials such as status reports, newsletters, templates, study manuals/binders, etc.
- Conduct quarterly QC of allocated studies/sites in the eTMF rendering to the company's oncology SOPs.
- Keep updated on site information, this involves all contact details and distribution lists for reports and clinical supplies.
- Work alongside other members of the project team to meet sponsor, protocol and company goals of regulatory promptness which involves contract and budget deliberations when needed.
- Offer assistance to project management through ongoing project reports and updates.
- Form and uphold efficient, regular communications with study sites, offering study updated and assistance to sites in a timely manner.
- Recognise and raise data quality concerns to guarantee clinical data integrity.
- Conduct ongoing management of necessary regulatory documentation at the outset as well as across the lifespan of a study.
- Contribute to the performance of pre-qualification, initiation, regular monitoring, remote monitoring, and close-out visits rendering to pertinent SOPs.
- Other duties to be assigned.
Key Skills and Requirements:
- Educated to a degree level in a biological or human-connected field or corresponding work experience.
- Demonstrable experience in a clinical research associate role with a background in managing clinical trial sites.
- Familiarity with supervising oncology early phase studies.
- Know-how of ICH regulations and GCP which involves comprehension of regulatory needs.
- Expertise on the drug development process and the company's organisational structure.
- Exhibits a professional attitude with good customer orientation.
- Interpersonal and communication skills both verbally and in writing.
- Works well both independently as well as in a team.
- Able to multitask and manage time efficiently.
- An organised individual with computer literacy.
- Competent working remotely as well as absorbing and implementing expertise gained through both internal and external trainings on protocols allocated.
- Willing to travel for business needs.
- Fluency English as well as 2 other languages being either French, Spanish, Dutch or German.
If you are having difficulty in applying or if you have any questions, please contact Jack Wingrove at +44 203 831 7675.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.