Senior Clinical Research Associate - Oncology, Rare Disease - Japan

Who we are

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.

Why Worldwide

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!

What Clinical Operations does at Worldwide

At Worldwide Clinical Trials, we invite you to embark on a rewarding journey within Clinical Operations, where your contributions will leave a profound impact on the lives of patients.  

As a Clinical Research Associate (CRA) at Worldwide, you will find yourself working alongside brilliant minds across diverse therapeutic areas, including Neuroscience, Oncology, Cardiovascular, Metabolic and Rare Diseases. Collaboration with top-tier colleagues from various backgrounds and specialties is not just encouraged; it's ingrained in our culture. Our commitment to advancing clinical research is nurtured within a supportive and team-oriented environment. In a CRA role, you'll receive extensive support through regulatory submissions, TMF management, and in-house CRAs for projects with heavy site management needs.   

What you will do

• Responsible for site qualification, initiation, interim monitoring, site management, and study close-out visits. 

• Provide mentoring and guidance to less experienced CRAs and site staff when needed. 

• Document site visit findings via written reports. 

• Assess, monitor, and train study site staff on protocol adherence as required. 

• Review study subject safety information and informed consent. 

• Conduct source document verification for compliance, patient safety, and veracity of data. 

• Review CRFs using paper or electronic data capture systems and assist sites with data query resolution. 

• Provide applicable updates for site related documentation for filing in the Trial Master File (TMF). 

• Ensure site compliance with IP receipt, accountability and return or destruction. 

• Conduct accompanied site visits for assessment or training of other CRAs as requested and appropriate. 

What you will bring to the role

• Excellent interpersonal, oral, and written communication skills in English

• Superior organizational skills with attention to details

• Ability to work with little or no supervision

• Proficiency in Microsoft Office, CTMS and EDC Systems

Your experience

• 2+ years of experience as a Clinical Research Associate

• 4-year university degree or RN/BSN in Nursing

• Experience in Oncology and Rare Disease is required

• Willingness to travel required

We love knowing that someone is going to have a better life because of the work we do. 

To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

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.