Clinical Research Coordinator

Salma Health, Inc.; San Diego (CA); On-site; USD 72,000 - 90,000; Full time

Job summary

Salma Health, Inc. is seeking a Clinical Research Coordinator to manage day-to-day operations of clinical studies in our La Jolla clinic.

You will ensure compliance with FDA regulations, GCP, and ICH guidelines while acting as the main contact for sponsors, IRBs, and participants. Responsibilities include coordinating trials from startup to closeout, coordinating IRB submissions, data entry in REDCap/Medidata, and mentoring junior staff.

Qualifications

• Bachelor's degree in health science, life science, nursing, or related field.
• Minimum 2 years of clinical research experience with Phase I–III trials or equivalent.
• Working knowledge of FDA regulations, GCP, and IRB processes.
• Proficiency with electronic data capture systems and Microsoft Office Suite.
• 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.

Responsibilities

• Coordinate all operational aspects of assigned clinical trials from startup through closeout.
• 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.
• Recruit, screen, and schedule study participants in accordance with protocol eligibility criteria.
• Conduct study visits, collect data, and perform protocol-specified assessments per training and delegation.
• Maintain ongoing communication with participants to support retention and protocol adherence.
• Enter and verify data in EDC systems (e.g., REDCap, Medidata Rave) with accuracy and timeliness.
• Ensure all study activities comply with FDA regulations (21 CFR Parts 50, 54, 56, 312, 812), ICH E6 GCP, and SOPs.
• 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 or volunteers as needed.

Skills

Communication skills

Organization

Multitasking

Attention to detail

Education

Bachelor's degree in health/life sciences

Tools

REDCap

Medidata Rave

Microsoft Office

Job description

The Clinical Research Coordinator (CRC) is responsible for the day-to-day operational management of clinical research studies conducted at Salma Health. Working under the supervision of the Clinical Research management team, the CRC ensures that all research activities are conducted in compliance with federal regulations, institutional policies, and Good Clinical Practice (GCP) guidelines. This role serves as the primary point of contact for study sponsors, IRB submissions, and research participants.

Location: The role requires working 5 days a week in person in our La Jolla clinic.

Key Responsibilities:

Study Management & Operations

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

• 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

Participant Coordination

• Recruit, screen, and schedule study participants in accordance with protocol eligibility criteria

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

• Maintain ongoing communication with participants to support retention and protocol adherence

Data Management

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

Regulatory & Compliance

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

• Facilitate and support sponsor monitoring visits, internal audits, and regulatory inspections

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 or volunteers as needed

Required Qualifications:

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

• Minimum 2 years of clinical research with experience running Phase I-III clinical trials or equivalent combination of education and experience

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

• Proficiency with electronic data capture systems and Microsoft Office Suite

• 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

Preferred Qualifications:

• Familiarity with REDCap, Medidata Rave, or similar EDC platforms

• Bilingual or multilingual skills are a plus

Compensation & Benefits

The compensation for this position includes:

• Base: $72,000- $90,000 (depending on experience & 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.

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

At Salma Health, we are transforming the mental and neurological brain healthcare paradigm from a disjointed, one-size-fits-all approach to a comprehensive, end-to‑end brain healthcare system featuring advanced diagnostics, evidence-based rapid‑acting interventions, and care coordination under one roof.

Through a streamlined system of continuous monitoring and support, Salma Health’s system will deliver much‑needed improved outcomes for conditions such as major depressive disorder, PTSD, bipolar disorder, and other conditions with imminent risk, as well as neurodegenerative disorders.

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're happy to help.