Clinical Research Associate job in

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

SECTION 1: POSITION SUMMARY

• Identify, select, initiate and close-out appropriate investigational sites for clinical studies.
• Monitor those sites in order to ensure that studies are carried out according to the study protocol and in accordance with ICON SOPs/WPs applicable regulations and the principles of ICH-GCP.
• Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues.

SECTION 2: JOB FUNCTIONS/RESPONSIBILITIES

• 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 is 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.(International and domestic: fly and drive)
• *Expert knowledge of ICON’s SOPs/WPs, ICH, GCP and appropriate regulations.
• *Familiarity with ICON systems.
• *Maintain timelines. Ensure accuracy and completeness of data entered into ICON systems.
• Recruitment of investigators.
• *Independent and proactive coordination of all the necessary activities required to set up and monitor a study, including but not limited to the following:
- Identify investigators.
- Help when requested, in preparation of regulatory submissions.
- Design of patient information sheets and consent forms.
- Ensure timely submission of protocol/consent documents for ethics/IRB approval.
- 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 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.
- Participate in feasibility studies for new proposals as required.
- Ensure correct archiving of files on completion of a study.
- Maintain patient and sponsor confidentiality.
- Assume additional responsibilities as directed by the Project Manager.
- Investigational 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.
• *Act in a lead role on a study assuming additional responsibilities as detailed/documented by the Project Manager if appropriate.
• Participate in data listing reviews, as applicable.
• *Responsible for cost effectiveness
• *Participate in training and mentoring new staff up to Clinical Research Associate level as appropriate.
• Assist with marketing the company if and when appropriate.
• Other duties as assigned.

SUPERVISION

• *Ability to mentor, train and/or supervise other Clinical staff as appropriate.

SECTION 3: EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• US/LATAM/CAN: Experience should include monitoring skills. Experience should be a minimum of 2 years of active independent field monitoring and site management experience
• EU/APAC: Experience should include monitoring skills. Prior relevant active independent field monitoring experience and site management experience.
• Ability to review and evaluate clinical data.
• Computer literacy desirable.
• Foreign language skills desirable.
• Good oral and written communication skills.
• Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employee’s location, the employee may be required to possess a valid Drivers license.

SECTION 4: EDUCATION REQUIREMENTS

• Bachelors degree, or local equivalent, in medicine, science or related discipline.

Benefits of Working in ICON

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies 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 you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

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

A better career. A better world. A better you.

Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader.
See all locations

Read more

List #1

Day in the life

Home Sweet Office: Why Culture Compatibility Matters

Teaser label

Inclusion & Belonging

Content type

Blogs

Publish date

04/29/2024

Summary

Cultural Fit in the Workplace Finding the perfect cultural fit is crucial when searching for a new employer. It goes beyond just the job description and salary package. Cultural fit refers to how

Teaser label

Explore how aligning with the right company culture can transform your work environment into a home away from home.

Precision Medicine: How Personalised Therapies are Transforming Healthcare

Teaser label

Industry

Content type

Blogs

Publish date

04/29/2024

Summary

Precision medicine is a groundbreaking approach that aims to revolutionise healthcare by tailoring medical treatments to individual patients. Unlike traditional medicine, which adopts a one-size-fi

Teaser label

Discover how precision medicine is revolutionising healthcare by tailoring treatments to each patient.

Day in the life of a Clinical Data Mangement Project Manager

Teaser label

Our People

Content type

Blogs

Publish date

04/29/2024

Summary

Deepak is a Clinical Data Management Project Manager at ICON Strategic Solutions, the largest global provider of Functional Service Provision (FSP). He works as a dedicated resource within one of o

Teaser label

Deepak shares his experience as Clinical Data Management Project Manager at ICON Strategic Solutions.

View all

Similar jobs at ICON

Clinical Site Manager

Salary

Location

Reading

Department

Clinical Monitoring

Location

Reading

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

We are recruiting experienced UK-based Senior CRAs who are looking for a developmental role - with a strong ability to build relationships at site (involved in problem solving and data review). You w

Reference

2024-110167

Expiry date

01/01/0001

Read more Shortlist Save this role

CRA II

Salary

Location

India

Department

Clinical Monitoring

Location

India

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us

Reference

2024-110031

Expiry date

01/01/0001

Author

Kalpana Kulasekaran

Author

Kalpana Kulasekaran

Read more Shortlist Save this role

CRA II

Salary

Location

India

Department

Clinical Monitoring

Location

India

Remote Working

Office Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

Reference

2024-110030

Expiry date

01/01/0001

Author

Kalpana Kulasekaran

Author

Kalpana Kulasekaran

Read more Shortlist Save this role

Senior Statistical Programmer II

Salary

Location

India, Chennai

Location

Bangalore

Chennai

Trivandrum

Bengaluru

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Programming

Job Type

Permanent

Description

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I

Reference

JR117921

Expiry date

01/01/0001

Author

Caroline Sweety

Author

Caroline Sweety

Read more Shortlist Save this role

Principal Statistical Programmer

Salary

Location

India, Bangalore

Location

Bangalore

Chennai

Trivandrum

Bengaluru

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Programming

Job Type

Permanent

Description

Reference

JR115256

Expiry date

01/01/0001

Author

Caroline Sweety

Author

Caroline Sweety

Read more Shortlist Save this role

Senior Principal Biostatistician

Salary

Location

UK, Reading

Location

Reading

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Biostatistician

Job Type

Permanent

Description

About the roleAs a Senior Principal Biostatistician you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. What you will be do

Reference

JR118408

Expiry date

01/01/0001

Author

Jonathan Cunliffe

Author

Jonathan Cunliffe

Read more Shortlist Save this role

Full Service

ICON Strategic Solutions

Government and public health services

Global Business Services

Overview of Service Lines

Why icon? full service mean for you?

graduate What does full service mean for you?

Clinical Research Associate

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

A better career. A better world. A better you.

Who we are