Senior Clinical Research Associate

Senior Clinical Research Associate ( Senior CRA) - Remote - Bulgaria

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 an experienced Senior Clinical Research Associate 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.

• The CRA is 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.

• The CRA proactively identifies potential issues and develops site Corrective Actions / Preventive Actions (CAPAs) and ensures timely and sufficient resolution of issues that may impact compliance or quality of study related activities or data.

• As key contributor to the Trial Master File and study documents at the country level, ensures essential documents are appropriate and filed in a timely manner in the Investigator Site File.

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

Your profile

• University degree

• a CRA with a minimum of 3.5 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

• Ability to work occasionally form the sponsor's office in Sofia

• Good IT skills

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

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

#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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized 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