Clinical Research Associate Job

SENIOR CLINICAL RESEARCH ASSOCIATE needed for a contract opportunity with Yoh's client located in South San Francisco, CA.

What You Should Be Doing:
- Provides direction and leadership to one or more clinical operations teams
- Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management.
- Builds effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables.
- Creates team culture and promotes team spirit. Develops and maintains effective working relationships with SMT members, with particular focus on affiliate teams, external CRO (for outsourced teams) and co-development partner study teams.
- In collaboration with functional management, coaches, mentors, supports, and provides study specific direction to Study Management team members.
- Oversees the development and maintenance of study specific manuals created by the GSA.
- Contributes to the development and management of the study timelines, resources, budget, risk and quality plans
- Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the GSL.
- Develops and manages clinical study budgets (including HQ budget) and contributes to staffing/resourcing plans.
- Communicates variances in the budget and action plan for resolution to the GSL.
- Establishes study milestones and ensures accurate tracking and reporting of study metrics.
- Provides operational input into the development of protocol feasibility questionnaires

What You Need to Bring to the Table:
- Experience Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in a Global environment and/or including monitoring or leading affiliate teams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock
- Experience of project managing operational aspects of a clinical study including development of timelines, budgets and resource plans.
- Good knowledge of ICH GCP
- Proven ability to successfully achieve results within a multi-cultural and geographically diverse team.
- Experience of working as part of a large team and leading small study or functional teams, with a proven ability to be an active member of the team and motivate and lead a small team to deliver against commitments.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a DayJ2W: SCIENTIFIC

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