SCRA (Clinical Research Associate) - Major Pharma

Proclinical are recruiting for a SCRA (Clinical Research Associate) - Major Pharma to join a CRO. This role is on a permanent basis with the ability to work remotely from anywhere in Germany.

Responsibilities:

• 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.

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