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.
- 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 firstname.lastname@example.org.
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.