Clinical Research Program Manager - Quality Outcome & Grant Writing
Pacific Neuropsychiatric Specialists · Irvine, CA · 5 days ago
On-siteProject ManagementFull-time
Position Summary
We are seeking a Clinical Research Program Manager to help develop and support the clinical outcome research program in mental health and substance use at Pacific Neuropsychiatric Specialist (PNS).
Primary Responsibilities
- Establish and maintain research infrastructure for an independent outpatient psychiatry research program.
- Prepare and manage Institutional Review Board (IRB) submissions, amendments, continuing reviews, and regulatory documentation.
- Develop research protocols, informed consent documents, case report forms, and standard operating procedures.
- Career outcomes research projects from study initiation through publication.
- Perform literature reviews and summarize current scientific evidence.
- Draft manuscripts, abstracts, white papers, and conference presentations under the direction of the Principal Investigator.
- Organize references using citation management software (e.g., EndNote, Zotero, or Mendeley).
- Assist with data organization, quality assurance, and preparation of tables and figures for publication.
- Career with statisticians, collaborators, and journal editorial offices as needed.
- Maintain study files and ensure compliance with applicable regulatory and ethical requirements.
Minimum Qualifications
- Master's degree (e.g., MPH, MS, MA, or related field).
- At least 2 years of experience in clinical research, research administration, or clinical study coordination, especially in psychiatry.
- Experience preparing and managing IRB submissions.
- Excellent scientific and grant writing and editing skills.
- Strong organizational and project management abilities.
- Proficiency with Microsoft Office and reference management software.
Preferred Qualifications
- Experience conducting literature reviews and preparing manuscripts for peer-reviewed journals.
- Experience in value-based care highly preferred.
- Familiarity with REDCap or other clinical research databases.
- Experience with clinical outcomes research or behavioral health research.
- Working knowledge of basic biostatistics and interpretation of clinical research findings.
Desired Attributes
- Exceptional attention to detail.
- Strong written and verbal communication skills.
- Ability to manage multiple projects simultaneously.
- Self-motivated with the ability to work independently.
- Collaborative and interested in building a research program from the ground up.