Clinical Assistant

Description The Bartech Group, one of America's largest and fastest-growing staffing firms, continues to elevate the staffing industry to a higher level of thinking. Bartech Enterprise Staffing specializes in temporary and direct placement of Engineering, IT, Technical, Finance & Accounting, and Professional staff.

Currently we are seeking individuals for the following position:
CLINICAL ASSISTANT

The Clinical Assistant is responsible for the delivery of multiple clinical studies from synopsis development through reporting, submission and as needed regulatory defense activities within a program in alignment with the overall program timeline, cost and quality goals.

The CA is responsible for and manages study deliverables through internal and external resources and is a point of contact and interface between the study clinician, the study team and these functional groups, vendors and FSPs. The CA will champion operational excellence to provide continuous improvement of processes and sharing of best practices.

Job Responsibilities:
- Operational Delivery and Planning
- Contribute to the clinical study components of the development plan with respect to time, quality and operational feasibility.
- Ensure study-level resources are available to deliver individual studies to plan. - Facilitate budget finalization.
- Facilitate the development and endorsement of the study level plan with the study team. - Partners with the Project Planner and Project Manager to ensure that schedule, cost, resource management, study quality are established and maintained between clinical study activities and the overall development plan.
- Active contributor to protocol development via participation in protocol design meetings to ensure operational consequences are factored into design decisions and appropriately represented when synopsis is signed off / endorsed.
- Translate the Development Plan goals into relevant, tangible and measurable goals for assigned studies. Ensure alignment across all disciplines of study team required to deliver a study.
- Maintain and enhance own knowledge in the relevant therapeutic/technical area and in global regulations/guidelines pertaining to clinical research.

Control & Execution of the Project
- Apply organization skills to deliver goals and coordinate the planning, initiation, completion and reporting of clinical studies from synopsis development to reporting.
Responsible for ensuring that individual clinical studies meet agreed time (including recruitment), quality & cost targets
- Participating in problem identification and drive resolution to ensure studies deliver in accordance with goals.

Risk Analysis and Management
- Responsible for ensuring clinical study risks are identified and communicated to the Clinician and Project Manager for integration into the program level risk management plan along with appropriate contingencies.

Requirements Skills Required to be considered:
- At least 5 years clinical operations and pharmaceutical business experience in order to have a thorough understanding of the processes associated with executing clinical development plans and addressing related regulatory issues.
- Leadership, excellent organization skills, resource management, administrative and technical capabilities are required.
- Effective verbal and written communication skills are required in relating to customers and colleagues both inside and outside the organization.
- Knowledge of team development principles and successful implementation required.
- Experience supporting regulatory submissions highly desired.
- Drug development experience including familiarity with:
- Clinical study management and monitoring
- Data management
- Clinical & regulatory processes
- Regulatory submissions
- Project/process management
- Budget / expense management
- Experience of Vendor Management(preferred)

Minimum Education Required:
Bachelor's degree or equivalent in one of the disciplines related to life sciences, drug development or business.
Advanced degree is desirable.

When you join The Bartech Group you launch a career. We support you with a comprehensive benefit plan, offering exceptional medical, dental, and vision care; life and disability insurance; paid time off including holidays; and 401K.