Senior Clinical Research Coordinator

Salma Health•La Jolla, CA

1d•Onsite

About The Position

The Senior Clinical Research Coordinator (CRC) is the site-level owner for the onboarding and execution of clinical research studies at Salma Health, from sponsor engagement and study startup through closeout. Reporting to the Clinical Research leadership team and operating with significant autonomy, the Senior CRC is accountable for conducting all research activities in compliance with federal regulations, institutional policies, and Good Clinical Practice (GCP) guidelines. This role actively drives and manages relationships with study sponsors and CROs, and serves as the site’s primary point of contact for sponsors, IRB submissions, and research participants.

Requirements

Bachelor's degree in a health science, life science, nursing, or related field
Minimum 5 years of clinical research with experience running Phase I-III clinical trials or equivalent combination of education and experience
Demonstrated experience owning study startup end to end, including site feasibility, regulatory submissions, and site activation
Proven experience directly managing sponsor and CRO relationships, including hosting monitoring visits and resolving site-level issues independently
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
Prior clinical research experience in CNS, interventional psychiatry, or neuroscience
Experience administering psychiatric or neurological rating scales (e.g., for depression, PTSD, or TBI)
Experience as a lead or senior CRC mentoring junior research staff
Bilingual or multilingual skills are a plus

Responsibilities

Own and drive all operational aspects of assigned clinical trials from startup through closeout, serving as the primary site-level owner
Lead site-level 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
Lead site feasibility and qualification assessments, and represent the site at sponsor site-selection and initiation visits
Own study startup end to end, including essential document collection, regulatory submissions, and site activation, to drive studies to first-patient-in
Partner with research leadership on study budgets and Clinical Trial Agreements, and track site-level enrollment, milestones, and deliverables against sponsor timelines
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
Enter and verify data in electronic data capture (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 institutional SOPs
Host and lead sponsor monitoring visits, internal audits, and regulatory inspections as the site’s primary respondent
Own and actively manage relationships with study sponsors and CROs across feasibility, startup, and study conduct, serving as the site’s primary point of contact alongside the IRB and clinical departments
Proactively manage sponsor and CRO expectations on timelines and deliverables, anticipating and escalating risks to enrollment and study milestones
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