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Role Description

The Senior Clinical Trial Coordinator (Sr. CTC) will be responsible for supporting the clinical project team during all stages of a clinical study by carrying out day-to-day study activities. The Sr. CTC will develop, implement, and coordinate study procedures to successfully manage clinical studies. The Sr. CTC will perform diverse duties requiring analysis, sound judgment, attention to detail, and a high level of knowledge of study-specific documents.

• Act as the Subject Matter Expert and primary point of accountability and reconciliation for the Trial Master File (TMF) and the Investigator Site File (ISF).
• Manages the tracking, review, and collection of study-specific documents required in the site’s Regulatory Binder.
• Assist in tracking study activities and milestones by managing and maintaining study trackers and logs.
• Manages device accountability for clinical studies, including tracking, shipment, and reconciliation of devices.
• Administrative oversight of current vendors, including the creation and management of purchase orders.
• Ensure all payments and expenses are tracked against the study budget and reconciled. Regularly interface with the Finance Department on study accruals.
• Manages all aspects of study-specific payments (e.g., vendors, investigational study sites) in accordance with executed agreements and approved budgets.
• Provides agendas, meeting minutes, and action items for project team meetings.
• Maintains Sunshine Act Reporting records for assigned studies and reports timely updates to the Olympus Transparency Reporting Team and helps to reconcile any issues.
• Supports literature search activities as required.
• Ensures data quality by reviewing completeness and accuracy of study data, including facilitating the resolution of data queries under the guidance of the Clinical Research Associate (CRA), Data Management and/or the Clinical Project Manager to ensure compliance with specified study protocols.
• Oversee the design, development, and maintenance of clinical study tracking in the Project Plan Management Tool and provides routine reports/dashboards to study team members.
• Provides guidance, mentorship, and daily oversight for more junior CTCs assigned to specific clinical studies, as applicable.
• Contribute to process improvement initiatives within clinical operations.
• May participate in co-monitoring visits or other site visits based on experience and training provided by and under the guidance of the assigned CRA or assigned CPM.
• Maintain audit readiness of study documentation, and assisting with audit and inspection preparation, ensuring compliance with GCP, ICH and company standards.
• Other responsibilities as assigned.

Qualifications

• BA/BS or equivalent experience in scientific or healthcare disciplines.
• Minimum of two (2) or more years experience in clinical research, with medical device and/or pharmaceutical trials.
• Strong computer skills with proficiency with MS Windows-based applications.
• Working knowledge of ICH Good Clinical Practice guidelines.
• Excellent communication skills (oral and written).
• Strong organizational skills with attention to details.
• Ability to build and maintain positive relationships with management and peers.
• Ability to work independently and manage multiple tasks in a fast-paced environment.
• Ability to work effectively on cross-functional teams.
• Valid driver’s license.
• Ability to travel domestically up to 10%.

Requirements

• Previous experience with medical device trials (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**.
• Work-life integrated culture that supports an employee centric mindset.
• Offers onsite, hybrid and field work environments.
• Paid volunteering and charitable donation/match programs.
• Employee Resource Groups.
• Dedicated Training Resources and Learning & Development Programs.
• Paid Educational Assistance.