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Clinical Research Program Manager - Quality Outcome & Grant Writing Pacific Neuropsychiatric Specialists - 3.3 Irvine, CA Job Details Full-time $90,000 - $120,000 a year 18 hours ago Benefits Health insurance Dental insurance Paid time off Vision insurance 401(k) matching Qualifications Managing scientific research projects Medical writing Teamwork Citation management for reference services Filing Research industry grant writing Attention to detail Master of Science Regulatory submission editing and review Communication with regulatory authorities for clinical trials Managing projects Productivity software Ethical review application preparation Full Job Description 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). This position will work directly with the clinicians and data analysts to establish research infrastructure, manage regulatory processes, coordinate clinical outcomes research, and assist in preparing manuscripts and scholarly publications in mental health and substance use clinical care. The ideal candidate is organized, detail-oriented, and an excellent scientific writer with experience in clinical research administration. This role does not require independent grant writing or serving as a principal investigator but requires the ability to translate research concepts into well-organized protocols and publication-ready manuscript drafts and grants. 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. Coordinate clinical 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. Coordinate 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.

Pay:

$90,000.00 - $120,000.00 per year

Benefits:

401(k) matching Dental insurance Health insurance Paid time off Vision insurance

Work Location:

In person