Lead Site Clinical Research Coordinator

The Lead Site Clinical Research Coordinator (CRC) is the founding coordinator for Salma Health's Fremont clinic, responsible for establishing research operations at the site and managing day-to-day study conduct, including the ATLAS study and sponsored trials. The role reports directly to the VP of Clinical Research for site infrastructure buildout and works under PI supervision for study-specific activities, ensuring compliance with federal regulations, institutional policies, and GCP guidelines. The CRC may also support regulatory submissions across Salma Health trials, including the La Jolla and Laguna Hills sites, and serves as the primary point of contact for sponsors, the IRB, and research participants. As the site's portfolio expands, the role may grow to include team leadership.

Location: Fremont, CA (with regulatory support for La Jolla and Laguna Hills sites)

Responsibilities:

Study Management & Operations

Coordinate all operational aspects of assigned clinical trials from startup through closeout

Stand up research operations at the Fremont clinic, including site activation for ATLAS and sponsored trials

Serve as the primary contact to research vendors

Complete sponsor feasibility questionnaires to support new trial selection and site qualification

Assist in the development and review of study protocols, amendments, and informed consent documents

Maintain and organize study files, regulatory binders, and essential documents per ICH/GCP guidelines

Prepare and submit IRB applications, continuing reviews, amendments, and adverse event reports

Manage study supply inventory, including investigational product accountability logs

Participant Coordination

Screen, enroll, and schedule study participants in accordance with protocol eligibility criteria

Obtain and document informed consent, ensuring participants fully understand study procedures and risks

Conduct study visits, collect data, and perform protocol-specified assessments (e.g., vital signs, ECGs, phlebotomy and sample collection) per training and delegation

Maintain ongoing communication with participants to support retention and protocol adherence

Identify, document, and report adverse events and protocol deviations to the PI and IRB as required

Data Management

Enter and verify data in electronic data capture (EDC) systems (e.g., REDCap, Medidata Rave) with accuracy and timeliness

Respond to data queries and discrepancies from sponsors and monitors in a timely manner

Abstract and review medical records to support source document verification

Regulatory & Compliance

Support or manage regulatory submissions across Salma Health trials as assigned, including the La Jolla and Laguna Hills sites

Maintain Delegation of Authority (DOA) logs and staff training logs, ensuring they remain current, accurate, and inspection-ready

Ensure all study activities comply with FDA regulations (21 CFR Parts 50, 54, 56, 312, 812), ICH E6 GCP, and institutional SOPs

Plan, host, and run sponsor monitoring visits, and facilitate internal audits and regulatory inspections

Complete required training (e.g., CITI Program, GCP) and maintain certifications as appropriate

Collaboration & Communication

Serve as the primary liaison between study sponsors, CROs, the IRB, and clinical departments

Communicate study status, enrollment updates, and issues to the PI and research management team

Mentor and provide guidance to junior research staff, volunteers, or future team members as the site grows

Qualifications

Required

Bachelor’s degree in a health science, life science, nursing, or related field

Minimum 3 years of clinical research experience or equivalent combination of education and experience

Strong regulatory background with hands-on experience preparing and managing IRB and sponsor regulatory submissions

Working knowledge of FDA regulations, GCP guidelines, and IRB processes

Ability to perform phlebotomy, or willingness to obtain certification within an agreed timeframe after hire

Strong organizational skills with meticulous attention to detail

Excellent written and verbal communication skills

Ability to manage multiple priorities in a fast-paced research environment

Willingness to travel up to 25% across Salma Health sites (Fremont, La Jolla, Laguna Hills) as needed

Ideal Candidate

Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) credential

Current phlebotomy certification (e.g., CPT)

Experience with Phase I–III clinical trials in an academic medical center or hospital setting

Experience supporting multiple research sites or coordinating regulatory activities across locations

Familiarity with REDCap, Medidata Rave, or similar EDC platforms

Bilingual or multilingual skills are a plus

Company Mission & Vision

We are the brain health company of the future that integrates care delivery, technology innovation and research breakthroughs to better understand brain biology and diagnose, treat and ultimately cure brain disorders for all stages of life.

Who We Are

Salma Health is reimagining brain healthcare by building a comprehensive, end-to-end brain health system that integrates advanced diagnostics, rapid-acting interventions, and continuous care coordination under one roof.

Our multidisciplinary teams of psychiatrists, neurologists, neuropsychiatrists, therapists, and technologists collaborate to deliver personalized, compassionate care. By leveraging real-world data and precision brain health research, we deliver measurable, evidence-based outcomes at scale.

Headquartered in California, Salma Health is expanding access to innovative brain health services across the U.S., beginning with clinics in San Diego, Orange County, the Bay Area, and Los Angeles.

Compensation & Benefits

The compensation for this position includes:

Base Salary: $72,203 – $100,000 (depending on experience and qualifications)

Benefits: Medical, dental, vision, PTO, and additional benefits

We reserve the right to modify benefit offerings at any time, in accordance with applicable laws.

Work Authorization

Sponsorship for employment authorization may be considered on a case-by-case basis depending on the role and candidate qualifications.

Equal Opportunity & Accessibility Statement

We are committed to providing a workplace that is inclusive, respectful, and free from discrimination. We welcome applicants of all backgrounds and make employment decisions without regard to race, color, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, ancestry, citizenship, age, physical or mental disability, medical condition, genetic information, marital status, military or veteran status, or any other characteristic protected by California or federal law.

In accordance with the California Fair Chance Act, we will consider qualified applicants with arrest and conviction records.

If you require a reasonable accommodation during the application or hiring process, please contact us directly. We are happy to help.