Site Activation Specialist - Japan- Remote at Worldwide Clinical Trials | JP | Rezi

Site Activation Specialist - Japan- Remote at Worldwide Clinical Trials

Site Activation Specialist - Japan- Remote

Worldwide Clinical Trials · JP

2 weeks ago

Site Activation Specialist - Japan- Remote

Worldwide Clinical Trials · JP

21 days ago
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About the Role

As a Site Activation Specialist, you will be an integral part of our Site team, collaborating seamlessly to facilitate the efficient activation of clinical research sites. This role nurtures career development and growth, focusing on honing project management and strategic planning skills to advance within Site Activation and progress to Project Management or other Clinical Operations groups.

Responsibilities

  • 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 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 and the collection and analysis of Site Feasibility Questionnaires.

Requirements

  • A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science.
  • Minimum one year of experience in clinical research, preferably in site activation or regulatory-related function.
  • Previous experience within the pharmaceutical/CRO industry.
  • Good knowledge of ICH GCP, EU Clinical Trials Directive and other relevant clinical research conduct guidance.
  • Multilingualism preferred; fluent in local language; working knowledge of English.

Skills

  • Organizational and time management skills.
  • Aptitude for planning, strategizing, managing, monitoring, scheduling, and critiquing skills.
  • Strong ability to handle multiple tasks in a fast-paced and changing environment.
  • Proficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint.
  • Strong understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel.

Experience Level

  • Minimum one year of experience in clinical research

Education Level

  • A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science.

About the Company

  • We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
  • We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
  • Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
  • We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

Equal Opportunity

  • Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.