Clinical Research Associate

Reposted Yesterday
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Bucharest, București
In-Office
Senior level
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
Manage and monitor clinical trial sites, ensuring compliance and quality data collection for phase I-IV trials. Train staff and conduct audits.
Summary Generated by Built In
Clinical Research Associate - Hybrid - Bucharest, Romania

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 on our mission to shape the future of clinical development

We are looking to recruit experienced Clinical Research Associates to join our ICON FSP team and work in a sponsor dedicated role for a global biopharmaceutical company who are the leader in fastest growing modern healthcare such as cell & gene therapies (CGT), oncology, cardiology, women's health, hematology, and ophthalmology. 

What you will be doing:

  • Site management and monitoring activities for assigned applicable Phase I and all Phase II-IV clinical Investigator sites 

  • Conducts remote and onsite visits including but not limited to initiation visits, monitoring visits, close-out visits

  • Managing Investigator site and site activities and monitoring site data, to ensure patient safety and ethical and regulatory compliance  to provide quality data required for global regulatory submissions for approval of drugs.

  • Managing Investigator sites to ensure the Investigator and Site Staff meet all aspects of study delivery and commitments to make certain the operational study execution is on track from site selection to site close out.

  • You will be responsible for training the Investigator and site staff on these strict regulatory regulations and procedures for timely reporting and as well as ensuring ongoing compliance.

  • Contributor in the preparation, conduct and follow up of Site Audits and Regulatory Inspections to ensure a successful outcome. 

Your Profile:

  • University degree

  • minimum of 2 years of independent on-site monitoring experience in a bio/pharma/CRO

  • Proven Skills in Site Management including management of site performance and patient recruitment

  • Good IT skills

  • Ability to understand and analyze data/metrics and act appropriately

  • Capable of managing complex issues, works in a solution-oriented manner.

  • Ability to travel at least 60% of the time and should possess a valid driver’s license

#LI-DS1

#LI- Remote

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

  • Various annual leave entitlements

  • A range of health insurance offerings to suit you and your family’s needs.

  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.

  • Life assurance

  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 or submit a request here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply

Top Skills

Clinical Trial Management Systems
Crf Systems
Edc Systems
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The Company
HQ: Dublin
34,685 Employees
Year Founded: 1990

What We Do

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.

We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.

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