Clinical Trial Coordinator II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Purpose

Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. Provides administrative support for site activation activities. Aids the development of the critical path for site activation within assigned projects in support of rapid site activations. Represents the organization in the global medical research community. May develop collaborative relationships with investigators and site personnel. May develop a knowledge base of sites in the respective market through collaboratively working with company personnel. May act as a buddy during onboarding phase. Supports training of new staff and participates in departmental initiatives to aid in process improvements/enhancements.

Essential Functions

 According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities.

 Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system(s).

 Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads and line manager as appropriate.

 Analyzes and reconciles study metrics. Assists with clarification and resolution of findings related to site documentation.

 Assists with technical and administrative support for projects in collaboration with internal departments and team members.

 Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.

 Ensures that trial status information relating to activities is accurately maintained in the database and current at all times.

 Where applicable, develops and maintains relationship with client local affiliates.

 Champions the inclusion of Strategic Collaboration sites into the process.

 Trains new personnel in processes and systems.

 May support the maintenance of study specific documentation and global support with specific systems, tools and trackers, including, but not limited to, study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients and tracking of project level activity plans in appropriate system.

 May transmit documents to client and centralized IRB/IEC.

 May attend Kick off Meeting and take notes when required.

 May support scheduling of client and/or internal meetings.

 May support scheduling and organization of client and/or internal meetings with completion of related meeting minutes.

 Provides support as needed to coordinate with internal departments and ensure site start-up activities within the site activation critical path are aligned.

 Assists the project team with the preparation of regulatory compliance review packages.

 May support start-up team in Regulatory submissions.

 Occasionally works directly with site(s) to obtain documents related to site selection.

 Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Communicate with the team and appropriate clinical personnel regarding site issues and risks.

 Ensures an efficient, effective plan is in place for site contact and follow up. Ensure compliance with the plan and escalates concerns/non-compliance to management.