About The Position

The Nurse Practitioner/Physician Assistant (Sub-Investigator) plays a key role in maintaining the integrity and quality of clinical trials by ensuring compliance with federal, state, and local regulations, IRB requirements, and OMRC policies. In collaboration with the Principal Investigator (PI) or Medical Director, this position is responsible for accurately performing study visit procedures and collecting patient data in accordance with study protocols, while safeguarding the health, safety, and well-being of research participants. The NP/PA Sub-Investigator may also support select studies in a limited capacity as a Study Coordinator.

Requirements

  • Master’s Degree required
  • Licensed Nurse Practitioner/Physician Assistant
  • At least 2 years of clinical research or sub-investigator experience strongly preferred
  • Phlebotomy training required
  • IV and infusion experience required
  • Pediatrics 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

Nice To Haves

  • Candidates with a minimum of 1 year experience performing psychometric rating scales in a clinical setting or for clinical trials
  • Current or previous certifications to rate the following scales: MMSE, RBANS, GDS-15, QoL-AD, A-IADL-Q-SV, SCID-5-CT, MINI, LSAS, HAM-A/D, C-SSRS, MADRS, MGH-ATRQ, ISI, CGI, HDRS-17, PANSS, YMRS, ADAS-Cog, CDR

Responsibilities

  • Reviews, comprehends, and adheres to assigned study protocol.
  • Assists trial Investigators in screening and review of potential study participants' eligibility.
  • Conducts subject visits.
  • Maintains case report forms, patient charts and documentation.
  • Ensures that all clinical activities are carried out in accordance with established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements.
  • Collects and enters data as necessary.
  • Reviews lab results, imaging reports, and other study-specific reports.
  • Completes required protocol training

Benefits

  • A career opportunity with M3 Wake Research offers competitive wages of $50/hr - $70/hr for this role.
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