[Hiring] Senior Clinical Trial Coordinator @Olympus Corporation of the Americas

Role Description

The Senior Clinical Trial Coordinator (SCTC) is responsible for the coordination and administration of clinical trials under the direction of the Dir. Clinical Projects. The SCTC will develop, implement, and coordinate study and administrative procedures for the successful management of clinical trials. The SCTC will perform diverse administrative duties requiring analysis, sound judgment, attention to detail, and a high level of knowledge of study specific protocols. The SCTC will take on additional leadership responsibilities including onboarding, training, and mentorship of more junior Clinical Affairs team members. The SCTC will help organize responsibilities for more junior Clinical Affairs team members working directly with the Dir. Clinical Projects.

Job Duties

• Coordinates and supports activities for multiple studies under the direction of the Director of Clinical Projects.
• Assists the Clinical Affairs team with the development of study-specific documents.
• Responsible for the setup, maintenance, and archival of the Trial Master File (TMF).
• Collects and tracks regulatory documents for multiple studies to ensure TMF completeness and audit readiness.
• Supports drafting of Clinical Trial Agreements (CTAs), budgets, and study-specific Confidential Disclosure Agreements (CDAs).
• Creates study-specific Regulatory Binders and ships them to clinical sites.
• Manages all aspects of study-specific payments (e.g., vendors and sites) in accordance with executed agreements and approved budgets.
• Tracks payments and expenses against the department budget and regularly interfaces with the Finance Department regarding study accruals.
• Communicates with principal investigators, hospital research personnel, and legal staff to coordinate study execution.
• Provides support for study-specific meetings (e.g., investigator meetings, core team meetings, and Data Safety Monitoring Board (DSMB) meetings), including drafting and distributing meeting minutes.
• Assists with remote and/or on-site study monitoring activities.
• Assists the Clinical Affairs team with site training, including training on electronic data capture (EDC) systems and study protocols, as needed.
• Designs and updates study-specific newsletters and distributes final versions to clinical sites.
• Responsible for study device and equipment shipments, accountability, and reconciliation.
• Maintains Sunshine Act reporting records for assigned studies and provides updates to the Olympus Transparency Reporting team as needed.
• Ensures compliance with applicable clinical study regulations and Olympus SOPs, work instructions (WIs), and policies.

Qualifications

• Minimum of one year of experience working for a medical device/biotech/pharmaceutical company, preferably in a Medical Affairs-related function.
• Ability to support multiple projects for Olympus Clinical Affairs teams at different locations.
• Well organized, detail oriented, and accountable.
• Strong written, oral, and interpersonal communication skills.
• Flexible, self-motivated, and works well under pressure in a dynamic environment.
• Proficiency with Microsoft Office and electronic data capture (EDC) systems.
• Ability to travel up to 10% of the time.
• Position requires up to 15% domestic & 5% international travel.

Requirements

• Associates or Bachelor’s degree in a scientific, healthcare, or business related field is preferred.
• Some experience organizing and analyzing data preferred.

Benefits

• Competitive salaries, annual bonus and 401(k)* with company match.
• Comprehensive medical, dental, vision coverage effective on start date.
• 24/7 Employee Assistance Program.
• Free live and on-demand Wellbeing Programs.
• Generous Paid Vacation and Sick Time.
• Paid Parental Leave and Adoption Assistance*.
• 12 Paid Holidays.
• On-Site Child Daycare, Café, Fitness Center**.