Clinical Research Site Director

North Dakota

Wake Research
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Wake Research is a recognized leader in clinical research and one of the largest Phase I-IV clinical trial service companies in North America. Wake Research is owned by M3, Inc., a global healthcare services company. M3-Wake Research is an organization of integrated investigational sites, committed to excellence, working closely with and meeting the needs of biopharmaceutical, biotechnology, medical device, and pharmaceutical industries. M3-Wake Research's 23 sites, with over 35 years of clinical research experience, have conducted over 7,000 research studies for hundreds of pharmaceutical and biotech sponsors and CROs.Due to continued growth and expansion, we are seeking a Site Director in Wilmington, NC.

Manages site activities to ensure delivery of site targets as received from senior management. 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:

Including, but not limited to the following:

  • 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

Supervisory Responsibility: Yes

Education and Training Required: Bachelor's degree or equivalent and relevant formal academic experience. Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA) or equivalent certification, preferred.

Minimum Experience: 5+ years of relevant experience as a clinical research associate or clinical research coordinator is required. Must have experience managing trials.

Knowledge, Skill, Ability: 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

  • Competitive salary
  • Advancement and career opportunities
  • 401(k), 401(k) matching
  • Dental insurance
  • Disability insurance
  • Employee assistance program
  • Flexible spending account
  • Health insurance
  • Life insurance
  • Paid time off
  • Vision insurance
Date Posted: 06 September 2022
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