Description:

M3 Wake Research, Inc. is one of the largest independent clinical research site services companies in North America. Wake Research has more than 16 owned and managed research sites across 7 states in the US and continues to grow. Due to this continued growth, the company is seeking a Clinical Research Site Manager at our location in Tucson, AZ.

Responsibilities:

• Responsible for site assessments, pre-trial assessments, site initiation, subject recruitment and retention, monitoring and close-out
• Conducts pre-study site selection visits and assessments
• Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct
• Schedules staff to cover subjects' visit needs
• Conducts staff reviews
• Works to ensure enrollment goals of the study center are being met
• Monitors subject visits
• Supports the team and investigators in overall conduct of the trials
• Follows the established monitoring SOPs both corporate and clinical, as well as protocol for specific monitoring plan
• Works with QA/QC program prior to sponsor visit
• Oversees employees' work before monitoring
• Reviews budgets, including clinical research and physicians' costs
• Works with the corporate office to evaluate recruitment plans and study start up
• Oversees protocol, regulations, and compliance training; ensures training is up to date

Requirements:

• Neuropsych studies experience required
• 5+ years of relevant experience as a clinical research associate or clinical research coordinator is required
• Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA) or equivalent certification, preferred.
• Must have experience managing trials.
• Sound knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs.
• Solid teamwork, organizational, interpersonal, attention to detail, and problem-solving skills.
• Strong written and verbal communication skills
• An ability to consume, absorb, and analyze large amounts of information.
• Ability to multi-task, work under time constraints, work independently and cooperatively with interdisciplinary teams.
• Strong computer skills in appropriate software and related company clinical systems is required

Benefits:

• Competitive salary
• Comprehensive benefits package - Medical, Dental, Vision, Life, Long-term Disability and 401K
• Paid time off