Sr Clinical Research Associate & Local Start-Up Specialist Contractor (Ukraine)

Posted 15 Days Ago
Be an Early Applicant
Hiring Remotely in Ukraine
Remote
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
Lead and perform monitoring activities for clinical trials across site initiation, routine monitoring, and close-out. Ensure compliance with protocol, GCP/ICH, SOPs and regulations. Build site relationships, identify and resolve issues, and support regulatory, site-activation, contracting, and study start-up tasks while traveling throughout Ukraine.
Summary Generated by Built In

Bring your monitoring expertise to the forefront of innovation. We are looking for a Sr Clinical Research Associate (CRA) and Local Start-Up Specialist(LSUS) Contractor to join our A-team. As a SrCRA 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 SrCRA and LSUS contractor, 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 Ukraine.

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 5 years’ experience.
  • Strong understanding of ICH-GCP and regulatory guidelines.
  • Clear and confident communicator in English and local language.
  • Comfortable working independently and managing priorities.
  • Willingness to travel, as required.

Benefits

About Allucent

At Allucent, our mission is to shine a light on new therapies that improve lives. When you join our team, you’ll use your unique skills, expertise, and knowledge to forge meaningful partnerships with clients while helping them turn groundbreaking ideas into life-changing treatments.


If you’re passionate about advancing pharmaceuticals and biologics, fueled by an entrepreneurial spirit, and eager to collaborate with top minds across science, business, and operations, we’d love to connect. Together we can accelerate innovation and grow side by side, making a last impact on patients worldwide.


Together we SHINE. Find more information about our values.

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.”

Skills Required

  • Minimum 5 years experience leading clinical trial monitoring activities
  • Experience in complex trials, ideally oncology or rare disease
  • Strong understanding of ICH-GCP and applicable regulatory guidelines
  • Experience with site activation, contracting, and study start-up activities
  • Clear and confident communication in English and local language
  • Ability to work independently and manage priorities
  • Willingness to travel throughout Ukraine as required
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The Company
HQ: Cary, NC
1,436 Employees

What We Do

Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. The company is purpose-built through the convergence of leading providers to address this unmet need. Today, Allucent is a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, Allucent’s individualized partnership approach provides experience-driven insights and expertise to assist its clients in successfully navigating the complexities of delivering novel treatments to patients.

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