Clinical Research Associate
Bring your monitoring expertise to the forefront of innovation. 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. 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.
About the role
As a Clinical Research Associate (CRA) at Allucent, you will independently control and monitor investigational sites, proactively detect issues, and 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. You will take the lead on monitoring activities, owning your sites and relationships with investigators, and act as the bridge between sponsor and site to ensure trial integrity. This role is remote with travel throughout the United States.
You will mentor junior team members, contribute to our success, and be supported by a collaborative, experienced team.
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.
- Mentor and support junior CRAs, sharing knowledge and best practices.
Requirements
- Minimum of 3-5 years of experience leading monitoring activities in complex trials.
- Experience in complex therapeutic areas such as cell and gene therapy or radiopharmaceuticals preferred.
- Strong understanding of ICH-GCP and regulatory guidelines.
- Clear and confident communicator in English.
- Comfortable working independently and managing priorities.
- Willingness to travel throughout the United States as required.
- Mastery of all types of clinical monitoring visits.
Benefits
- Comprehensive benefits package (varies by location).
- Competitive salaries (varies by location).
- Departmental Study/Training Budget for professional development.
- Flexible working hours (within reason).
- Opportunity for remote/hybrid working depending on location (minimum 2 days in office per week for employees within reasonable distance from an office).
- Leadership and mentoring opportunities.
- Participation in our Buddy Program for new and existing employees.
- Internal growth opportunities and career progression.
- Financially rewarding internal employee referral program.
- Access to online soft-skills and technical training via internal platforms.
- Eligibility for our Spot Bonus Award Program for exceptional performance.
- Eligibility for our Loyalty Award Program for longstanding employees.