Lead Site Clinical Research Coordinator

Job Description

Job Description

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)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

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.

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.

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.

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

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.