Lead Site Clinical Research Coordinator

Salma Health•San Francisco, CA

1d•$72,203 - $100,000•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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