Clinical Trial Coordinator - Onsite Position - Columbus, Ohio

Orsini Healthcare•Columbus, OH

21d•$80,000 - $90,000•Onsite

About The Position

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. 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.

Requirements

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.

Nice To Haves

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

Responsibilities

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