Clinical Research Program Manager Quality Outcome Grant Writing

Pacific Neuropsychiatric Specialists Inc; Irvine (CA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Vision insurance

401(k) matching

Dental insurance

Job summary

Pacific Neuropsychiatric Specialists Inc is seeking a Clinical Research Program Manager to build and support the clinical outcomes research program in mental health and substance use. This role collaborates with clinicians and data analysts to establish research infrastructure, manage regulatory processes, and coordinate projects from initiation through publication.

The ideal candidate is organized, detail-oriented, and an excellent scientific writer with experience in clinical research

Qualifications

• Master's degree in a related field.
• At least 2 years of clinical research experience, especially in psychiatry.
• Experience preparing and managing IRB submissions.
• Excellent scientific, grant writing, and editing skills.
• Strong organizational and project management abilities.
• Proficiency with Microsoft Office and reference management software.

Responsibilities

• Establish and maintain research infrastructure for an outpatient psychiatry program.
• Prepare IRB submissions, amendments, continuing reviews, and regulatory documentation.
• Develop research protocols, informed consent documents, case report forms, and SOPs.
• Coordinate clinical outcomes research from study initiation through publication.
• Perform literature reviews and summarize current scientific evidence.
• Draft manuscripts, abstracts, white papers, and conference presentations under the PI.
• Organize references using 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.

Skills

Scientific writing

Grant writing

Project coordination

Organizational skills

Communication skills

Data interpretation basics

Education

Master's degree in MPH / MS / MA or related field

Tools

REDCap

EndNote

Zotero

Mendeley

Microsoft Office

Job description

Benefits:

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

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.