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 affiliate