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"At ICON, it's our People that set us Apart"

ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently, operates from 83 locations in 38 countries and has approximately 13,000 employees. Further information is available at www.iconplc.com

Senior CRA (Tokyo)

Role Responsibility

Recognize, exemplify and adhere to ICON's values which center around our commitment to People Clients and Performance.
As a member of staff, the employee I expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
Ability and willingness to travel at least 60% of the time
Expert knowledge of ICON Clinical Research SOPs/WPs, ICH, GCP and appropriate regulations.
Expert knowledgeable of ICON systems.
Maintain timelines. Ensure accuracy and completeness of data entered into ICON systems.
Recruitment of investigators.
Independent and proactive co-ordination of all the necessary activities required to set up and monitor a study, including the following:
Identify investigators.
Help, when requested, in preparation of regulatory submissions. Design patient information sheets and consent forms.
Co-ordinate documents translation, verification and back translations where required.
Ensure timely submission of protocol/consent documents/safety reports for ethics/IRB approval according to local requirements.
Pre Study/placement and initiation visits.
Conduct regular monitoring visits in accordance with the ICON site monitoring SOP/Sponsor site monitoring SOP, as appropriate
Maintain all files and documentation pertaining to studies. Motivate investigators in order to achieve recruitment targets. Complete accurate study status reports.
Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.
Keep the project manager or designees regularly informed.
Process case record forms to the required quality standards and timelines. Deal with sponsor generated queries in a timely manner.
Ensure the satisfactory close-out of investigator sites.
Participate, if requested, in the preparation of and review of study documentation, e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report.
Ensure correct archiving of files on completion of a study. Maintain patient and sponsor confidentiality.
Assume additional responsibilities as directed by Project Manager (PM)
Responsible for the conduct/management of any aspect(s) of a project, when requested and authorised by a Project Manager.
Act in a Lead role on a study, assuming additional responsibilities as detailed/documented by the Project Manager, if appropriate.
Co-ordinate and/or participate in feasibility studies for new proposals, as required. lnvestigational Products (IPs) stored and managed by the site:

Ensure storage conditions and acceptable supplies are provided
Ensure IPs are supplied only to eligible patients
Ensure IP receipt, use and return are controlled and documented
Ensure disposition of unused IP comply with regulatory requirement and are in accordance with the sponsor.

Be cost effective.
Participate in training and mentoring new staff up to Clinical Research Associate level as appropriate.
Participate in data listing reviews, as applicable.
Assist with marketing the company if and when appropriate.
Other duties as assigned.

Experience and Qualification

7+ years of monitoring experience in phase I~III trials as a CRA
Knowledge of ICG GCP guidelines and expertise to review and evaluate medical data
Native Japanese level and conversational English at least
Excellent communication and interpersonal skills, both written and verbal enabling you to deal with queries in a timely manner
Focus on streamlining our processes adding value to our business and meeting client needs
Recognize, exemplify and adhere to ICON’s values which center around a commitment to People, Clients and Performance
Independently and proactively coordinate the necessary activities required to set up and monitor a study

Benefits of Working in ICON

You will be working as a Leader with a great team of smart and energetic people. ICON will offer you a very competitive management benefits package. This does vary from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

What’s Next

Following your application, if you have the necessary skills and experience for this job you will be invited to an initial telephone interview with one of our dedicated recruiters who will be able to provide you with more details of this opportunity.

ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment

Application process

Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.

Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.

One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.

Reasonable Accomodations

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Full Service

ICON Strategic Solutions

Government and public health services

Global Business Services

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Senior CRA

About the role

This vacancy has now expired. Please see similar roles below...

ICON and you

ICON history

Career Pathways

Benefits & Rewards

DE&I

Environmental, Social & Governance

Women in IT

Application process

Who we are

Government and public health services

Why icon? full service mean for you?

Senior CRA

Send me a message

About the role

This vacancy has now expired. Please see similar roles below...

ICON and you

ICON history

Career Pathways

Benefits & Rewards

DE&I

Environmental, Social & Governance

Women in IT

Application process

Who we are