Site Activation Specialist (SAS)

Proclinical are partnering with a CRO who are currently recruiting for an individual to join their team. This role is on a permanent basis. The opening position is for a Site Activation Specialist.

Responsibilities:

• Accomplish, handle and/or assist with country and site-specific actions necessary to activate sites for a clinical trial when suitable and when needed.
• You might support SAM colleagues by advising them to foster quality delivery throughout the division.
• The ideal candidate might assist with regulatory actions under direction when required for critical delivery or for professional self-development if ideal.
• Gather, receive and conduct first evaluation of necessary study-specific site regulatory/necessary documents rendering to suitable SOPs, regulations, and pertinent study specific plans.
• Execute corrective action when required, prior to necessary document evaluation sign off and follow up on non-Hold items post sign off.
• Offer local follow up and update status of local EC proposals to the pertinent teams allocate to the project.
• Familiarise yourself with and comply to SOPs, ICH GCP and any other suitable guidelines.
• Any other assigned duties.

Key Skills and Requirements:

• Educated to a degree level with a major in a medical, biological, physical, health, pharmacy or similar scientific field.
• At least 1 year of experience working within clinical research, ideally within site activation or regulatory-linked function.
• Familiarity working within a pharmaceutical/CRO industry.
• Expertise in ICH GCP, EU clinical trials directive and any other pertinent clinical research.
• Fluency in the Japanese language with knowledge in English.
• An organised individual with the ability to manage own time efficiently.
• Capable of planning, strategising, managing, monitoring, scheduling, and critiquing skills.
• A motivated individual keen to learn present regulatory procedures and knowledge.
• Able to share knowledge and train others within and beyond own division.
• Communication skills both verbally and in writing.
• Adaptable to constantly shifting settings.
• Capable of prioritising workload with a high attention to detail.
• Able to handle various tasks simultaneously within a fast-paced and changing setting.
• Computer literacy.
• Skilled with contemporary digital systems would be beneficial.
• Works well in a team.
• Comprehension of country level cultural norms and local healthcare systems.
• Capable of initiating and developing relations with local investigators and key site personnel.
• Comprehension of clinical research principles and procedure.

If you are having difficulty in applying or if you have any questions, please contact Erik Tarpley at e.tarpley@proclinical.com.

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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