Senior Clinical Assistant

1. Responsible for executing assigned tasks to ensure project deliverables are met

2. Use technical knowledge and experience to work with the study manager and others as required proactively identifying and anticipating issues and developing possible solutions

3. Keep up to date with information and disseminate as necessary/required

4. Liaise with outside vendors as directed to ensure study deliverables are met. For trials using external vendors contribute to documentation, and set up activities to facilitate efficient work flow

5. Support investigator meeting preparation and collection/distribution of materials

6. Liaise between the centralized group and the Study Manager for issues and status related to oversight of the Investigator Initiation Package (IIP) process

7. Responsible for maintaining study information on a variety of databases (e.g., registry), tracking this information and preparing status reports as required. Review for data inconsistencies within and across various databases. Take appropriate corrective actions to resolve issues that are identified

8. Responsible for ordering clinical trial supplies, applies technical knowledge to recognize problems or delays. Takes action to prevent or address issues, informs Study Manager as appropriate

9. Manage clinical, regulatory and study-related documents; review documents for completeness, accuracy and compliance with protocol and appropriate regulations10. Responsible for ensuring all study documents are archived based on the appropriate guidelines/policy.

11. Act as a Subject Matter Expert (SME) for various teams, committees, lines and workshops when requestedQualificationsAssociate degree (or equivalent) preferred

• It is likely that someone suitable for this position would have greater than 2 years business experience in order to have an understanding of the processes associated with a regulated environment/ clinical and study management operations preferred

• Ability to take responsibility for and organize tasks, time and priorities for their responsibilities/deliverables of a team’s milestones

• Technical/computer capabilities are required with a sound understanding of project requirements and the ability to manage multiple activities

• Excellent verbal and written communication skills in relating to colleagues and associates both inside and outside the organization

• Ability to work in loosely defined problem-solving situations within a study team to solve simple to moderately complex problems

• Ability to work under limited supervision

• Ability to apply technical skills and department knowledge to achieve assigned work within own project team