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Under the direction of clinical trials administrative management, interprets policies and implement procedures for the program, ensure compliance with KP HealthPlan and governmental agencies.

Prepares for audits and inspections by internal and external auditors, including coordination of the development of corrective action plans and follow-up

Provide support during internal and external audits. Assure audit readiness.

Collaborates with PI and Sponsor in establishing, implementing, and conducting clinical trials

Develop budgets

Evaluate potential protocols to determine feasibility, resource requirements, etc.

Establishes and maintains effective partnerships to ensure region-wide communication and coordination of the clinical trials program, fostering teamwork

Serve as a mentor and content expert to research staff.

Resolve complex operational and personnel issues.

Assists licensed and non-licensed research staff to effectively maximizes quality and compliance with clinical research standards, participant safety, and staff and member satisfaction.

Identify training needs, develop materials and coordinate training.

Collaboratively develops strategies and implement protocol-specific operating procedures to improve the quality of research and patient care.

Assist in developing and implementing departmental policies and procedures.

Assist in development of clinical trials technology systems and infrastructure.

Recruits and hires new clinical research staff.

Effectively manage staff, budget, resource/allocation planning, and performance assessments for a variety of clinical, regulatory and research functions.

Client conducts compensation reviews of positions on a routine basis.  At any time, Client reserves the right to reevaluate and change job descriptions, or to change such positions from salaried to hourly pay status.  Such changes are generally implemented only after notice is given to affected employees.