Medical Monitor – Psychiatry

We are seeking an experienced Medical Monitor with deep expertise in psychiatry to provide medical oversight for clinical trials focused on Major Depressive Disorder (MDD), ADHD, anxiety disorders, and Binge Eating Disorder (BED).

The ideal candidate is a psychiatrist or advanced practice psychiatric clinician with significant pharmaceutical, biotechnology, or CRO clinical trial experience and a strong background in psychiatric drug development. This individual will serve as the medical expert for assigned studies, ensuring participant safety, protocol compliance, and high-quality clinical data.

Preferred Qualifications

Candidates will be considered in the following order of preference:

• MD (Psychiatrist) with substantial psychiatric clinical trial experience
• Psychiatric Mental Health Nurse Practitioner (PMHNP) or Registered Nurse (RN) with significant psychiatric clinical trial experience
• Clinical Nurse Specialist (CNS) with relevant psychiatric and clinical research experience

Key Responsibilities

• Serve as the Medical Monitor for psychiatric clinical trials throughout study conduct.
• Provide medical oversight to ensure participant safety and protocol compliance.
• Interpret clinical trial protocols and provide medical guidance to investigative sites and study teams.
• Review subject eligibility, including inclusion and exclusion criteria, and provide medical consultation on enrollment decisions.
• Review case report forms (CRFs), medical histories, adverse events, and other clinical data for medical accuracy and consistency.
• Collaborate with sponsors, CROs, investigators, and cross-functional teams to resolve medical and protocol-related questions.
• Support protocol deviations, safety assessments, and medical review activities throughout the lifecycle of the study.
• Contribute clinical expertise to the development and execution of psychiatric clinical research programs.

Required Qualifications

• Direct clinical experience diagnosing and treating patients with:
  • Major Depressive Disorder (MDD)
  • Attention-Deficit/Hyperactivity Disorder (ADHD)
  • Anxiety Disorders
  • Binge Eating Disorder (BED)
• Prior Medical Monitor or equivalent clinical research experience within a pharmaceutical company, biotechnology company, or Contract Research Organization (CRO).
• Demonstrated experience with:
  • Clinical protocol interpretation
  • Subject eligibility review
  • Medical review of Case Report Forms (CRFs)
  • Clinical data review and protocol compliance
  • Good Clinical Practice (GCP) and ICH guidelines

Preferred Skills

• Excellent clinical judgment and medical decision-making skills.
• Strong understanding of psychiatric drug development and clinical trial methodology.
• Exceptional communication and collaboration skills with investigators, sponsors, and multidisciplinary study teams.
• Ability to manage multiple studies in a fast-paced clinical research environment.

If you are passionate about advancing innovative psychiatric therapies and ensuring the highest standards of participant safety and scientific integrity, we encourage you to apply.

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