You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.

Company Information

Our client company

Job Summary

Our client is seeking a Sub-Investigator who will provide medical oversight for clinical trials, primarily focusing on psychiatry/CNS studies across Phases I–IV. This role is crucial for assessing participant eligibility and safety, performing protocol-required clinical assessments, and ensuring all studies are conducted in strict compliance with the protocol, ICH-GCP, and FDA regulations.

Key Responsibilities

• Conduct clinical trials under the direction and delegation of the Principal Investigator in accordance with the protocol, ICH-GCP, FDA regulations (21 CFR Parts 50, 54, 56, and 312), IRB requirements, and company SOPs.
• Provide medical oversight across a portfolio of five or more concurrent studies, Phases I–IV, with a focus on psychiatry/CNS indications.
• Assess participant eligibility by reviewing medical and psychiatric history, concomitant medications, and inclusion/exclusion criteria prior to enrollment and randomization.
• Conduct and document the informed consent process, ensuring participants understand study procedures, risks, and their rights.
• Evaluate, document, and report adverse events (AEs) and serious adverse events (SAEs), including severity and relationship to investigational product, within protocol-required timelines.
• Review psychiatric safety assessments, including suicidality screening, and escalate safety concerns to the Principal Investigator per protocol and company SOPs.
• Ensure participant safety, rights, and well-being are protected throughout study participation.
• Perform physical examinations and other protocol-required clinical assessments at screening and study visits.
• Review vital signs, ECGs, and laboratory results for clinical significance and document investigator assessment.
• Perform blood draws and other study procedures as needed, within scope of licensure and delegation.
• Make protocol-driven decisions on investigational product dosing, holds, and discontinuation within scope of licensure and in consultation with the Principal Investigator.
• Document all assessments and investigator decisions in source documents in a timely, accurate manner consistent with ALCOA+ principles.
• Review and sign off on source documents, case report forms (CRFs), and EDC entries as delegated.
• Respond to data queries and monitor findings in a timely manner.
• Perform only those study tasks delegated by the Principal Investigator and documented on the Delegation of Authority log.
• Maintain current regulatory documents, including CV, license, GCP training, financial disclosure, and Form FDA 1572 listing.
• Participate in site initiation visits, investigator meetings, monitoring visits, and sponsor/CRO communications as required.
• Collaborate with Clinical Research Coordinators, Clinical Raters, and research staff to ensure protocol compliance and quality participant care.
• Support audit and inspection readiness, including participation in sponsor audits, regulatory inspections, and internal quality reviews.
• Complete all required SOP training and company-required trainings as assigned and when updated.
• Maintain all required licenses and certifications and ensure they remain current and in good standing.
• Travel to company meetings, site locations, or study-related activities as required.
• Perform other duties as assigned.

Qualifications

• Prior therapeutic area experience in Psych/CNS.
• Ability to manage a current or anticipated study load of 5 plus studies.
• Experience with trial phases I - IV.
• Ability to occasionally draw blood and perform physical exams.

Experience

• Minimum of 1 year of research experience.

Skills

• Proficiency with Spreadsheet Software (Excel), Word Processing Software (Word), Electronic Mail Software (Outlook), and Presentation software (PowerPoint).
• Experience with EDC systems (e.g., Medidata Rave, REDCap).
• Experience with CTMS and/or eRegulatory/eTMF platforms (e.g., Veeva).
• Experience with EMR/EHR systems.
• Strong attention to detail and accuracy.
• Ability to manage multiple tasks and priorities.
• Strong organizational and time management skills.
• Ability to work independently and as part of a team.
• Effective communication and interpersonal skills.

Education

• Minimum education: NP or PA.
• Required certifications/licenses: Medical license.

Additional Requirements

• No travel required.
• Expected work schedule is 3-4 days per week / 20-24 hours per week; specific days and hours will be set with the site based on study visit needs.
• Fluency in Spanish is preferred.

Benefits

• Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances).
• Health Benefits / Dental / Vision (Medix offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s)).
• 401k (Eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1).
• Short Term Disability Insurance.
• Term Life Insurance Plan.

^*We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).

Medix Overview:

With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we’re dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.

^*This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.