Position Summary
The Sub-Investigator / Clinical Trial Rater supports the Principal Investigator (PI) in the conduct and oversight of clinical research studies. This role is responsible for performing protocol-specific assessments, evaluating participant eligibility, conducting clinical procedures, and ensuring study activities are carried out in compliance with Good Clinical Practice (GCP), FDA regulations, and study protocols.
The individual will play an active role in participant care, informed consent discussions, safety monitoring, and data collection while helping protect the health, rights, and well-being of study participants. Depending on site needs, this position may also provide study coordination support.
Key Responsibilities
- Provide participant education and clinical consultations under the supervision of the Principal Investigator.
- Perform study-related physical examinations, assessments, and follow-up visits.
- Administer protocol-required psychometric and cognitive rating scales, including but not limited to CDR, ADAS-Cog, MMSE, C-SSRS, Cognitive Battery Tests, ESS, and other validated instruments.
- Review, understand, and adhere to assigned study protocols and procedures.
- Collaborate with the Principal Investigator to assess and determine participant eligibility.
- Maintain accurate and complete source documentation in accordance with GCP standards.
- Ensure all research activities comply with applicable regulations, study protocols, institutional policies, and industry standards.
- Work closely with multidisciplinary clinical research teams to support study execution.
- Review laboratory findings, imaging reports, and other study-related clinical data.
- Verify participant medical histories and clinical information collected by site staff.
- Communicate effectively with participants and, when applicable, caregivers, informants, or study partners.
- Participate in sponsor meetings, investigator meetings, conference calls, webinars, and ongoing training activities.
- Complete all required GCP, protocol-specific, and sponsor-mandated training within established timelines.
- Conduct participant interviews in compliance with FDA, ICH-GCP, HIPAA, and protocol requirements.
- Maintain current knowledge of applicable clinical research regulations, standards, and best practices.
- Support participant recruitment, community outreach initiatives, and retention efforts.
Qualifications
Education & Licensure
- Master's degree or an equivalent combination of education, training, and relevant experience.
- Licensed Advanced Practice Registered Nurse (APRN) with graduation from a CCNE- or ACEN-accredited program; or
- Certified Physician Assistant (PA-C) who has completed an ARC-PA accredited Physician Assistant program.
- Active and unrestricted license to practice in the state of employment.
- No history of FDA debarment or professional license suspension.
- Current BLS and ACLS certifications required.
- PALS certification required when supporting pediatric studies.
Experience
- Minimum of two (2) years of clinical practice experience.
- Training and experience in phlebotomy required.
- Experience performing bedside clinical procedures preferred.
- Two (2) years of experience serving as a Sub-Investigator in clinical research preferred.
- Pediatric clinical experience preferred.
Knowledge, Skills & Abilities
- Minimum of one (1) year of experience administering psychometric rating scales in a clinical or research setting.
- Experience or certification in administering assessment tools such as MMSE, RBANS, GDS-15, QoL-AD, A-IADL-Q-SV, SCID-5-CT, MINI, LSAS, HAM-A, HAM-D, C-SSRS, MADRS, MGH-ATRQ, ISI, CGI, HDRS-17, PANSS, YMRS, ADAS-Cog, and CDR is highly preferred.
- Strong understanding of FDA regulations, ICH-GCP guidelines, and applicable clinical research standards.
- Excellent organizational, interpersonal, and problem-solving skills.
- Exceptional attention to detail and ability to maintain accurate documentation.
- Strong verbal and written communication skills.
- Ability to manage multiple priorities, meet deadlines, and work effectively both independently and within a collaborative team environment.
- Proficiency with electronic clinical research systems, sponsor platforms, and standard computer applications.
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).
*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.
