CNS Contract Clinical Research Associate, NE US

Category: CRA
Job #: 10931
Utilization: 5%
Location: Northeast
Job Type: 1099
Therapeutics: CNS; Psychiatry and/or Behavioral

Join a pioneering study at the forefront of neuropsychiatric innovation. We are looking for a regulatory-savvy CRA to oversee a breakthrough therapy trial involving a federally monitored substance. This high-impact, low-utilization contract offers the rare opportunity to shape the future of depression treatment while maintaining the flexibility to manage your existing projects.

Job Responsibilities:
  • Act as the "Site Manager," ensuring relationships with site(s) are positive, issues are resolved quickly, and communications are strong across all verticals.
  • Assist with the development of study manuals, CRFs, monitoring standards, site study tools, and other study materials as required.
  • Develop and implement site recruitment, selection, and initiation plan.
  • Manage and drive patient recruitment and enrollment tracking.
  • Provide training to sites on the study protocol, study conduct, CRF completion, and data management expectations.
  • Ensure essential document collection for completeness per regulatory requirements.
  • Serve as a liaison with Investigators, Institutions, and sites to provide support during the conduct of the clinical trial and serve as a resource for protocol and procedures.
  • Demonstrate knowledge of on-site monitoring to ensure compliance with GCPs, study protocols, and SOPs.
  • Manage one or multiple studies.
  • Monitor product supplies/accountability, including proper storage, dispensation, and disposal.
  • Manage study completion activities, including CRF collection, query resolution, record archiving, and site closeout activities.
  • Review in-house data and study tables.
  • Mentor, coach, and provide guidance to clinical staff as appropriate.
  • Supervise and train other employees as appropriate.
Job Qualifications:
  • A minimum of 5 years’ experience as a fully dedicated regional, home-based, field monitor for a CRO, or Pharma is required. This monitoring experience must be recent, having been no longer than 2 years ago.
  • A minimum of 1 year of experience monitoring CNS studies, with a focus on Psychiatry and/or Behavioral studies.
  • Previous experience monitoring clinical trials involving Schedule I controlled substances, with a demonstrated mastery of DEA processes, strict chain-of-custody protocols, and site-level storage and security requirements.
  • Be able/willing to commit to a small utilization (estimated 5% effort), traveling for site visits (a single site) every 6 months over a three-year time period.
  • Nice to have: previous experience monitoring Psychedelic-assisted-therapy studies, which included psychoactive drugs.
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