Clinical Research Associate

Clinical Research Associate

Real Life Sciences' dedicated pharmaceutical and biotechnology division has been working with pharmaceutical companies, biotechnology organizations, and professionals across both sectors since 1998 and has focused on providing added-value recruitment services for companies working within development phases 1 to 4.

We work with large multinational companies, generics and biosimilar manufacturers, small niche biotech organizations, and all parts of the pharma and biotech supply chain, including R&D companies, clinical research organizations, manufacturing companies, marketing and medical communications agencies, and regulatory affairs consultancies.

Real Life Sciences' success within pharma and biotech recruitment is based on our ability to understand our key markets and develop a business that is focused on supporting our customers as their challenges change and the industry evolves.

Job Description

Position Summary :

Responsible for the conduct of clinical study activities to verify and validate new instrument platforms, assays, and biomarkers developed by Ventana Medical Systems. Works closely with study managers and other CRA staff to complete all CRA functions associated with study planning, implementation, monitoring, and closing study conduct in accordance with the principles of Good Clinical Practice (GCP).

Essential Functions :

• Conducts in-house monitoring, and may independently perform on-site monitoring in accordance with Roche and Ventana Standard Operating Procedures, ICH GCP guidelines, and Regulations.
• Participates in assessing study risks.
• Communicates on behalf of the study manager with investigators and site staff.
• Prepares study performance reports and provides input into study budgets.

Study Implementation :

Departmental Roles :

Qualifications

Formal Training / Education :

Bachelor of Science, RN, or BSN; OR equivalent combination of education and experience.

Experience :

Knowledge, Skills and Abilities :