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Clinical Research Associate, Clinical Sciences
- The Clinical Research Associate (CRA) supports Lead CRA in the areas of product development and commercialization through the execution of Clinical Trials. CRA has knowledge of Clinical Project Processes and can execute trial related activities with or without guidance as necessary. The Clinical Project Specialist is familiar with internal Clinical SOPs, has knowledge of GCPs and understands the Clinical Study Protocol.
・ Contributes to protocol, ICF, IB and Reg submission creation.
・ Executes CDAs and supports creation of CSAs and site budgets.
・ Attends Clinical Project Meetings and manages Meeting Minutes.
・ Executes study payments, manages device tracking/accountability and responsible for site management activities.
・ Uses internal systems to update project milestones and study timelines.
・ Manages Master study file.
・ Creates site Regulatory binders and other site materials.
・ Manages and controls CROs for site management including monitoring.
Quality System Requirements
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
A seasoned, experienced professional with a understanding and wide application of principle, theories, and concepts in the field. Applies a understanding of area of specialization to resolve a wide range of issues in creative ways. General knowledge of other related disciplines, business unit function and cross group dependencies/relationships. This job is the fully-qualified career-oriented position.
Develops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors. Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a broad knowledge of a variety of alternatives and their impact on the business unit.
Planning and Organization ：
Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule and priorities. Plans and organizes assignments and maintains schedules.
Discretion/Latitude; Supervision Received; Decision Making
Works under general direction regarding the direction and progress of projects and special assignments. Independently determines and develops approach to solutions. Interprets, executes and recommends modifications to company policies. Assists in establishing departmental policies and procedures. Work is reviewed upon completion for adequacy in meeting objectives.
Business Relationships and Project Management ：
Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. May interact with vendors. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represents a specialized field in larger project teams. Influences middle management on business solutions.
Impact Contributes to the completion of specific programs and projects. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.
Interacts with senior internal and external personnel on significant matters often requiring coordination between organizations. Uses discretion, diplomacy and tact to resolve difficult situations. May escalate serious issues to manager.
Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel.