Clinical Research Sub-Investigator: PMHNP or PA with CAQ in Psychiatry

Job Description

Job Description

Clinical Research Sub-Investigator: Psychiatric Mental Health Nurse Practitioner or Physician Assistant with CAQ in Psychiatry

Job Type

Full Time

Employment Level

Senior-Level

Experience Required

2+ Years

Work Setup

On-Site Work

Job Description

Job Summary:

Austin Clinical Trial Partners is seeking a motivated and detail-oriented board-certified Psychiatric Mental Health Nurse Practitioner (PMHNP) or PA with CAQ in psychiatry to join our practice as a Sub-Investigator in clinical research trials focused on psychiatric conditions. The ideal candidate will have experience in both psychiatric clinical care settings and in clinical research. A Sub-Investigator will collaborate closely with the Principal Investigator (PI), clinical research staff, and sponsors to ensure the safe and compliant execution of studies. This is an exciting opportunity to leverage your clinical expertise to contribute to the advancement of medical science and improve patient outcomes through innovative research initiatives in mental health. Austin Clinical Trial Partners is a leading clinical research organization specializing in psychiatric and central nervous system (CNS) disorders. We are committed to advancing medical knowledge and improving treatment outcomes through innovative and ethical clinical research.

Key Responsibilities:

• Function as a Sub-Investigator (Sub-I) : Assist the Principal Investigator in implementing clinical trial protocols, ensuring adherence to study procedures, timelines, and regulatory requirements specific to psychiatric trials.
• Maintain current knowledge of investigational products, protocol requirements, and study-specific procedures. Provide ongoing psychiatric support and medication management as needed during the trial.
• Participant Recruitment: Screen and enroll eligible participants into psychiatric clinical trials, utilizing effective recruitment strategies to meet enrollment targets while ensuring compliance with study protocols and inclusion/exclusion criteria.
• Obtain and document informed consent from potential study participants, ensuring thorough comprehension of study procedures, risks, and benefits related to psychiatric interventions.
• Conduct study visits and follow-up appointments, administering psychiatric assessments, mental status exams, and diagnostic evaluations of study participants per protocol to assess eligibility of potential subjects based on inclusion/exclusion criteria.
• Accurately document participant data in source documents, case report forms (CRFs) and electronic data capture (EDC) systems ensuring accurate and timely completion of study documentation, maintaining compliance with Good Clinical Practice (GCP) guidelines and applicable regulations specific to psychiatric research.
• Monitor participant safety throughout psychiatric clinical trials, promptly documenting and reporting adverse events and serious adverse events to the Principal Investigator and regulatory authorities as per protocol and regulatory guidelines.
• Collaborate with the study team including clinical research coordinators, data managers, and regulatory affairs personnel to facilitate efficient study conduct and ensure protocol compliance and participant safety throughout the clinical trial. Ensure data integrity through high-quality data collection, including resolution of psychiatric research-related issues.
• Participate in site initiation visits (SIVs), monitoring visits, audits, webinars, teleconferences, meetings, and study protocol trainings to further learn about the field and specific research studies. Complete required institutional and protocol-specific training. Travel to Investigator, educational, and business development meetings as needed.
• Conduct pre-screens to select qualified prospective candidates based on specific inclusion/exclusion criteria, prohibited medications, protocol intensity, etc.
• Demonstrate excellent relationship skills with ACTP team members and participants. Provide oversight and ensure proper delegation of duties to appropriate qualified staff. Ability to work collaboratively within a multidisciplinary team, fostering a culture of teamwork, professionalism, and mutual respect in the context of psychiatric research. Diversity training and bilingual capabilities are desirable.
• Maintain all required licenses to practice in the state of Texas. Ensure strict adherence to regulatory guidelines (FDA, IRB, ICH-GCP) and study protocol requirements.

Qualifications

Qualifications:

• Education: Master’s or Doctorate degree in Nursing with PMHNP certification or PA with CAQ in psychiatry
• Licensure: Active and unrestricted APRN license in Texas; Current nursing licensure in good standing (Nurse Practitioner). DEA license required or active PA license, unrestricted in good standing with CAQ in psychiatry.
• Certifications: GCP or clinical research certification a plus.
• Experience: Minimum 2 years of clinical experience in psychiatric care. Prior experience in clinical research preferred but not required (training provided).
• Strong documentation, assessment, and communication skills.
• Familiarity with DSM-5 diagnostic criteria and psychotropic medications.

Preferred Skills:

• Practical experience with standard psychometric and diagnostic scales, e.g. SCID-5, M.I.N.I. for DSM-5, HAMD and SIGH-D-17, SIGH-A, MADRS, C-SSRS, etc.
• Knowledge of clinical trial phases (I-IV), especially Phase II or III trials in psychiatry.
• Familiarity with electronic data capture (EDC) systems and medical records (EMR).
• Ability to manage multiple trials and adapt to dynamic research environments.
• Detail-oriented, organized, and committed to regulatory compliance.

Benefits:

• Competitive salary based on experience. $75.00 - $85.00 per hour
• Health, dental, and vision insurance.
• Continuing education and clinical research training opportunities.
• Retirement plan: 401(k) with match.
• Expected hours: 40-50 per week. Flexible scheduling and paid time off.

Job Code

CRNP