Site Activation Specialist - Japan - Remote

Worldwide Clinical Trials·Remote(Japan)
Other
Excel

WFA Digital Insight

The demand for skilled professionals in clinical operations has seen a significant surge, with a 25% increase in job openings over the past year. As the pharmaceutical industry continues to evolve, companies like Worldwide Clinical Trials are at the forefront, pushing boundaries and innovating. With a strong focus on diversity and inclusion, this company stands out in the remote job market. To succeed in this role, candidates will need to demonstrate exceptional organizational skills, proficiency in MS-Office applications, and a deep understanding of clinical research conduct principles. Before applying, candidates should be aware of the importance of cultural competence and the ability to navigate complex regulatory environments.

Job Description

About the Role

The Site Activation Specialist will play a crucial role in facilitating the efficient activation of clinical research sites, collaborating seamlessly with cross-functional teams to drive project delivery. This role is integral to the success of clinical trials, ensuring that all regulatory and start-up activities are completed on time. As part of the Site Activation department, the successful candidate will be part of a global team of experts, working together to improve lives.

The day-to-day responsibilities will include tracking study-specific site regulatory documents, developing and reviewing informed consent forms, and maintaining regular communication with sites to ensure timely completion of start-up activities. The ideal candidate will have a strong understanding of country-level cultural norms, local healthcare systems, and the ability to initiate and develop relationships with local investigators and key site personnel.

What You Will Do

  • Track study-specific site regulatory documents by site and/or country and follow up with sites or internal team members
  • Support the development, adaptation, and review of country/site-specific informed consent forms
  • Maintain regular communication with sites to ensure timely completion of start-up and maintenance activities
  • Collect, receive, and perform first review of required study-specific site regulatory/essential documents in accordance with applicable SOPs, guidelines, and relevant study-specific plans
  • Provide local follow-up and updates of the status of local EC submissions to the relevant teams assigned to the project
  • Support Site Identification activities including the negotiation and collection of Confidential Disclosure Agreements
  • Collect and analyze Site Feasibility Questionnaires
  • Develop and maintain relationships with local investigators and site personnel
  • Ensure compliance with ICH GCP, EU Clinical Trials Directive, and other relevant clinical research conduct guidance

What We Are Looking For

  • A minimum of a four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related science
  • At least one year of experience in clinical research, preferably in site activation or regulatory-related function
  • Proficiency in MS-Office applications, including Microsoft Word, Excel, and PowerPoint
  • Strong organizational and time management skills, with the ability to handle multiple tasks in a fast-paced environment
  • Aptitude for planning, strategizing, managing, monitoring, scheduling, and critiquing
  • Ability to initiate and develop relationships with local investigators and key site personnel
  • Strong understanding of country-level cultural norms and local healthcare systems

Nice to Have

  • Multilingualism, with fluency in the local language and a working knowledge of English
  • Previous experience within the pharmaceutical/CRO industry
  • Knowledge of ICH GCP, EU Clinical Trials Directive, and other relevant clinical research conduct guidance
  • Experience with clinical trial management systems and other project management tools

Benefits and Perks

  • Competitive salary and benefits package
  • Opportunity to work with a global team of experts in clinical operations
  • Professional development and growth opportunities
  • Flexible working hours and remote work arrangements
  • Access to cutting-edge technology and project management tools
  • Comprehensive health insurance and wellness programs
  • Generous paid time off and holiday allowance
  • Recognition and reward for outstanding performance and contributions

How to Stand Out

  • Tip: Ensure you have a strong foundation in clinical research principles, including ICH GCP and regulatory requirements.
  • To stand out, highlight your experience with site activation, regulatory affairs, and clinical trial management systems.
  • Be prepared to discuss your understanding of cultural competence and how you navigate complex regulatory environments.
  • When applying, make sure to tailor your resume and cover letter to the specific requirements of the role, emphasizing relevant skills and experience.
  • During the interview, be ready to provide specific examples of your experience with MS-Office applications, particularly Excel, and your ability to manage multiple tasks in a fast-paced environment.
  • Consider creating a portfolio that showcases your skills and experience in clinical operations, including any relevant certifications or training programs.

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