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)

• 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…