Clinical Research Coordinator

Salma Health•La Jolla, CA

23d•$72,000 - $90,000•Onsite

About The Position

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

Requirements

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

Nice To Haves

Familiarity with REDCap, Medidata Rave, or similar EDC platforms
Bilingual or multilingual skills are a plus

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