Clinical Research Associate II

3 days ago


Bucharest, Bucureşti, Romania Allucent Full time

Bring your monitoring expertise to the forefront of innovation. We are looking for a Clinical Research Associate (CRA II) to join our A-team (hybrid). As a CRA II at Allucent, you will independently control and monitor investigational sites, pro-actively detect issues, provide solutions to ensure clinical studies are performed according to the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice.

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. At Allucent we are big enough to deliver and small enough to care. We know all our colleagues by name and work together as a team to make everyone SHINE.

The role

As a CRA II, you will take the lead on monitoring activities, owning your sites and relationships with investigators. You'll be the bridge between sponsor and site, ensuring trial integrity while being supported by a collaborative, experienced team. This includes work related to regulatory affairs, site activation processes—including contracting and start-up activities—to ensure smooth and compliant study execution. You will travel throughout Romania. This

Main responsibilities:

  • Independently manage all aspects of monitoring for assigned clinical trials across study phases, including site initiation, routine monitoring, and close-out visits.
  • Ensure compliance with protocols, GCP, ICH, SOPs, and applicable regulatory requirements.
  • Build strong site relationships, acting as a primary point of contact and ensuring high-quality data collection.
  • Identify and resolve site issues, escalating as needed to maintain trial integrity and patient safety.
  • Activities around regulatory affairs, site activation and study-startup.

Requirements

You're an experienced CRA ready to take the next step with a company that truly values your expertise and independence. You thrive in an agile, collaborative environment and want to be part of a team making a real impact.

  • Experience leading monitoring activities in complex trials, ideally in oncology or rare disease with a minimum of at least 3 years' experience.
  • Strong understanding of ICH-GCP and regulatory guidelines.
  • Clear and confident communicator in English and Romanian.
  • Comfortable working independently and managing priorities.
  • Willingness to travel in Romania , as required.

Benefits

  • Competitive salaries and a comprehensive benefits package
  • Departmental Study/Training for furthering professional development
  • Mentoring opportunities
  • Internal growth opportunities and career progression
  • Financially rewarding internal employee referral program
  • Eligibility for our internal employee recognition programs for going above and beyond on projects
  • Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees

About Allucent

Our mission is to help bring new therapies to light. When you work at Allucent, that means applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.

If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.

Together we SHINE. Find more information about our values.

Apply now

If you are interested in this role please apply through the button or for more information reach out to Yael Kokernoot,

Disclaimers:

*Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

"The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources."

 #LI-YK1 #LI-remote



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