Lead Clinical Research Coordinator
Encino , CA 91316
Posted 2 weeks ago
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Pharmacology Research Institute (PRI) is a clinical trials company specializing in the evaluations of new medications since 1975. PRI is part of M3 Wake Research, Inc., one of the largest independent clinical research site services companies in North America with more than 15 owned and managed research sites across seven states in the US.
M3 Wake Research Inc. is currently seeking a Lead Clinical Research Coordinator at our PRI location in Encino, CA to oversee all aspects of the clinical trials management and to act as a point of contact in site management practices.
- Responsibilities include: site assessments, pre-trial assessments, site initiation, subject recruitment and retention, monitoring and close-out
- Conducting pre-study site selection visits and assessments
- Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct
- Scheduling of staff to cover subjects visit needs
- Reviews, comprehends, and adheres to assigned study protocol
- Assists trial investigators in screening and review of potential study participants' eligibility.
- Conducting staff reviews
- Work to assure enrollment goals of the study center are being met
- Monitor subject visits
- Support the team and investigators in overall conduct of the trials
- Follow the established monitoring SOPs both corporate and clinical as well as protocol for specific monitoring plan
- Work with QA/QC program prior to sponsor visit
- Oversee employees work before monitoring
- Review budgets that clinical research costs and physicians costs are covered
- Work with the corporate office for evaluating recruitment plans and study start up
- Oversee training for all protocol trainings as well as required for regulations, compliance and up to date training
- 3+ years of 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
- Training in phlebotomy is required
- Previous Neuroscience experience preferred
- 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
- 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
- Paid time off
- Advancement and career opportunities