Senior Clinical Trial Coordinator

Working Location: Nationwide. Workplace Flexibility: Remote.

About the role

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives. Our five Core Values empower us to achieve Our Purpose: Patient Focus, Integrity, Innovation, Impact and Empathy.

Responsibilities

• 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.
• Takes on additional leadership responsibilities including onboarding, training, and mentorship of more junior Clinical Affairs team members.
• Helps organize responsibilities for more junior Clinical Affairs team members working directly with the Dir. Clinical Projects.

Requirements

• 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 (MS Word, MS Excel, MS Outlook, MS PowerPoint).
• Ability to travel up to 10% of the time (up to 15% domestic & 5% international travel).

Qualifications

Preferred:

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

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 (location-specific).
• Paid volunteering and charitable donation/match programs.
• Employee Resource Groups.
• Dedicated Training Resources and Learning & Development Programs.
• Paid Educational Assistance.

Pay

The anticipated base pay range for this full-time position is $68,481.00 - $92,449.00 per year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay range represents the National Average of the range and may vary depending on the location of the individual.