Sub-Investigator / Clinical Rater

Piper Companies is seeking a Sub-Investigator / Clinical Rater to join a collaborative clinical research environment supporting regulated clinical trials. This role partners closely with the Principal Investigator to ensure the safe, compliant, and accurate execution of study protocols while maintaining adherence to FDA, ICH, and GCP standards. This Sub-Investigator is a full-time position located in Mission Viejo, CA.

Responsibilities for the Sub-Investigator / Clinical Rater include:

·      Conducting participant consultations and providing education during research visits under PI oversight.

·      Performing protocol-defined physical exams, screening evaluations, and follow-up visits.

·      Administering standardized and semi-structured clinical and psychometric rating scales according to study protocols.

·      Reviewing study protocols and ensuring all visit procedures are completed accurately and on time.

·      Assisting the PI with participant eligibility assessments and clinical decision-making when delegated.

·      Completing study documentation in compliance with GCP, FDA, and institutional requirements.

·      Ensuring all clinical activities align with applicable regulatory standards, policies, and procedures.

·      Collaborating with multidisciplinary research, clinical, and operational teams.

·      Conducting participant interviews in accordance with FDA, ICH-GCP, and HIPAA guidelines.

Qualifications for the Sub-Investigator / Clinical Rater include:

·      Master’s degree or equivalent combination of education, training, and relevant experience.

·      Licensed Advanced Practice Registered Nurse (APRN) from an accredited CCNE or ACEN program or licensed Physician Assistant (PA-C) from an ARC-PA–accredited program.

·      Active, unrestricted license to practice in the state of employment.

·      Current BLS and ACLS certifications; PALS required if working with pediatric populations.

·      Minimum of 2 years of hands-on clinical practice experience.

·      At least 1 year of experience administering psychometric or clinical rating scales in a research or clinical setting.

·      Preferred experience or certification with scales such as MMSE, ADAS-Cog, CDR, C-SSRS, HAM-D/A, MADRS, CGI, PANSS, YMRS, and related assessments.

·      Working knowledge of FDA regulations, ICH-GCP guidelines, and clinical research standards.

Compensation for the Sub-Investigator / Clinical Rater includes:

·      Salary range: $110,000 - $140,000

·      Comprehensive benefits package including Medical, Dental, Vision, 401k, PTO, holidays, and sick leave as required by law.

Keywords: sub-investigator, clinical trials, good clinical practice, GCP, ICH-GCP, FDA regulations,

HIPAA, protocol adherence, regulatory compliance, clinical research operations, participant safety,

study visits, psychometric rating scale, ADAS-Cog, CDR, MMSE, C-SSRS, HAM-D, HAM-A, CGI, PANSS, YMRS, ESS, phlebotomy, bedside procedures, medical history review, APRN, PA-C license, PALS, pediatric advanced life support, EMR, CTMS  

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This job is open for applications on 4/21/2026 and will remain open for at least 30 days from the posting date.