Clinical Trial Coordinator

Careers with real impact.

Every role at Orsini moves a patient closer to life-changing therapy. We partner with biopharma innovators, healthcare providers, and payers to make access simple, compassionate, and reliable - so no patient is left behind. Make your next role matter.

ABOUT ORSINI

Providing compassionate care since 1987, Orsini is a leader in rare disease and gene therapy pharmacy solutions, built to simplify how patients connect to advanced medicines. Through our comprehensive commercialization solutions including a nationwide specialty pharmacy, patient services hub, home infusion and nursing network, and third-party logistics provider, we work with biopharma, providers, and payors to ensure No Patient is Left Behind™

OUR MISSION

Orsini is on a mission to be the essential partner for biopharma innovators, healthcare providers, and payers to support patients and their families in accessing revolutionary treatments for rare diseases. Through our integrated portfolio of services, we seek to pioneer comprehensive solutions that simplify how patients connect to advanced therapies while providing holistic, compassionate care so that No Patient is Left Behind™.  

CORE VALUES

At the heart of our company culture, the Orsini LIVE IT Core Values serve as guiding principles that shape how we interact with each other and those we serve. These values are the driving force behind our commitment to excellence, collaboration, and genuine care in every aspect of our work.

COMPENSATION & LOCATION

The salary range for this role is $80,000-$90,000.

This on-site position based out of our Columbus, Ohio. Travel to other locations may occur, although minimal.

POSITION SUMMARY

The Clinical Trial Coordinator will oversee and manage the dispensing operations for clinical trials and Early Access Programs for Orsini. This role ensures compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards while coordinating with sponsors, CROs, investigators, and internal pharmacy teams. The position is critical for maintaining accuracy, integrity, and timely delivery of investigational products to trial participants. 

Essential Duties

• Serve as the primary liaison between the specialty pharmacy, clinical trial sponsors, CROs, and clinical sites.  Provide timely updates on IP status, shipment schedules, and dispensing activities.  
• Coordinate all pharmacy-related activities for assigned clinical trials, including investigational product (IP) receipt, storage, dispensing, and accountability.   Ensure adherence to study protocols, sponsor requirements, confidentiality, and regulatory guidelines. Maintain accurate documentation for IP handling, including temperature logs, chain of custody, and dispensing records.   
• Ensure compliance with state and federal pharmacy laws, clinical trial regulations, and specialty pharmacy accreditation standards.    
• Prepare for and support audits and inspections by sponsors, CROs, and regulatory authorities.    
• Manage investigational product inventory, including reconciliation and returns in conjunction with the inventory management team.    
• Implement quality assurance processes to ensure accuracy and prevent protocol deviations.    
• Train pharmacy staff on study-specific requirements and handling procedures.    
• Maintain SOPs and ensure proper documentation for all trial-related activities

Disclaimer: The information written in this job description indicates the general nature and level of work to be performed. This job description is not designed to contain or be interpreted as totally comprehensive of every job duty, responsibility, or qualification required by an employee assigned to this job. While employed in this position, an employee may be required to perform other assignments not listed in this job description.  

KNOWLEDGE, SKILLS, AND TRAINING

• Pharmacy Technician License. 
• Bachelor’s degree in Life Sciences, or related field.   
• Minimum 2–3 years of experience in clinical trials or investigational drug services.   
• Familiarity with GCP, FDA regulations, and clinical trial operations.   
• Strong organizational and project management skills.   
• Excellent communication and collaboration abilities.   
• Proficiency in clinical trial management systems and pharmacy dispensing software.

• Certified Clinical Research Coordinator (CCRC) or equivalent.   
• Specialty Pharmacy experience. 

• Medical Coverage, Dental, and Vision Coverage
• 401(k) with employer match
• Accident and Critical Illness coverage
• Company-paid life insurance options
• Generous PTO, paid holidays, and floating holidays
• Tuition reimbursement program.

Equal Employment Opportunity

Orsini Rare Disease Pharmacy Solutions is committed to the principle of Equal Employment Opportunity for all employees and applicants. It is our policy to ensure that both current and prospective employees are afforded equal employment opportunity without consideration of race, religious creed, color, national origin, nationality, ancestry, age, sex, marital status, sexual orientation, or present or past disability (unless the nature and extent of the disability precludes performance of the essential functions of the job with or without a reasonable accommodation) in accordance with local, state and federal laws.

Americans with Disabilities Act

Applicants as well as employees who are or become disabled must be able to perform the essential job functions either unaided or with reasonable accommodation. The organization shall determine reasonable accommodation on a case-by-case basis in accordance with applicable law.