The Clinical Research Site Director oversees site activities to ensure delivery of site targets as received from senior management. The Clinical Research Site Director provides direct or indirect supervision of all clinical and administrative aspects of a clinical trial within the research site to ensure delivery of targets and quality.
Essential Duties and 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
- Oversee the site financial performance
- Train and develop site staff. Ensure that site team understands and performs according to established KPI
- Bachelor's degree or equivalent and relevant formal academic experience.
- Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA) or equivalent certification, preferred.
- 5+ years of relevant experience as a clinical research associate or clinical research coordinator is required. Must have experience managing trials.
- 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 are required
A career opportunity with M3 Wake Research offers competitive wages, and benefits such as:
- 401(k), 401(k) matching
- Dental insurance
- Disability insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
*M3 reserves the right to change this job description to meet the business needs of the organization
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