Senior Clinical Trial Coordinator

Olympus Corporation of the Americas•Upper Saucon, PA

8d•Remote

About The Position

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.

Requirements

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%.

Nice To Haves

Previous experience with medical device trials

Responsibilities

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 activies and milestones by managing and maintaining study tackers 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.