Clinical Research Site Manager
Wake Research Los Alamitos, CA
- Posted: over a month ago
M3 Wake Research, Inc. is one of the largest independent clinical research site services companies in North America. Wake Research has more than 15 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 Los Alamitos, CA.
- 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
- 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
- Competitive salary
- Comprehensive benefits package - Medical, Dental, Vision, Life, Long-term Disability and 401K
- Paid time off
AddressLos Alamitos, CA
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