Clinical Research Coordinator

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: