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Clinical Research Associate

Employer
ICON Strategic Solutions
Location
Bulgaria, Homeworking
Salary
Competitive
Start date
30 Sep 2022
Closing date
4 Oct 2022

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Discipline
Clinical Research, Clinical Operations
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Summary of the role

This particular role is a client dedicated one where you will work exclusively on one sponsors trials and SOPs; a client that values their staff and puts an emphasis on career development.

You will be 100% client focused with a prestigious pharmaceutical company.

The CRA is the primary point of contact between site staff and sponsor. This CRA will be responsible for taking leadership of site management for the selection and initiation of sites on behalf of the sponsor, as well as conducting and closing activities of the appointed studies in compliance with local regulations, ICH- GCP, sponsor´s procedures and protocol requirements.

Responsibilities:

• Perform all type of visits from site feasibility to close out visits according to plan, document actions and follow up on action plans

• Train and guide site staff in safety information handling, systems, protocol and trial procedures to minimize protocol deviations

• Proactive use of EDC and other data source systems for preparation and conduct on site visits as well as source data verification in collaboration with data management/logistics team

• Identify potential risks and proactively take action to prevent or mitigate

• Collaborate with Data Management/logistics in resolving queries

• Assist to ensure data cleaning cycle timelines are met in accordance with the Data Flow Plan

• Motivate and build strong relations with site personnel to assist the sponsor in being their preferred clinical research partner

• Collaborate with and provide oversight of deliverables from vendors locally, if applicable

• Support the site in filing and archiving trial documentation in the Investigator Trial Master File (ITMF)

• Participate in Investigators Meetings to ensure relations with sites as well as active presentation as applicable

• Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements

• Support audits and inspections at sites and affiliate, as applicable

Qualifications:

• Bachelor or Master’s degree in life sciences or other relevant fields.

• Previous experience in independent on-site monitoring of clinical trials would be an advantage.

• Excellent knowledge of Clinical Trial Management Systems, Good Clinical Practices and Trial Management.

• Strong analytical and communication skills with business, industry understanding and stakeholder management.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Company

As the largest global provider of Functional Service Provision (FSP) with over 90 partnerships and 14,000+ employees, we have deployed FSP solutions across all major functions, from clinical monitoring and project management through data management, statistical programming, and beyond.

ICON Strategic Solutions teams are embedded in our clients' businesses, working as a dedicated resource within some of the world’s leading Pharmaceutical & Biotech companies. You will play a key role in helping to deliver cutting-edge research, working on novel therapies that deliver real impact.

Why choose a career with ICON Strategic Solutions?

Meaningful Work: You’ll contribute to cutting-edge projects that have a real impact on global healthcare. Your work will play a pivotal role in shaping the future of medicine and improving patient lives.

Collaborative Environment: We foster a collaborative and inclusive work culture that thrives on teamwork, diversity, and knowledge sharing. You'll have the opportunity to collaborate with industry-leading experts, learning from their experiences and growing both professionally and personally.

Innovative Technologies: At ICON Strategic Solutions, we embrace the latest technologies and tools to enhance our capabilities. You'll have access to state-of-the-art software and resources, empowering you to deliver high-quality results efficiently.

Career Growth: We value our employees and invest in their professional development. You'll have access to comprehensive training programs, mentorship opportunities, and a clear career progression path. We believe in recognizing and rewarding exceptional performance, providing ample scope for advancement within the organization.

Global Reach: Joining ICON Strategic Solutions means being part of a truly global company. With service capabilities in 92 countries, you'll have the chance to collaborate with colleagues from diverse backgrounds and gain exposure to projects with a global reach.

Company info
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