Senior Clinical Research Coordinator

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. Location The role requires working 5 days a week in person in our La Jolla clinic. Key Responsibilities Study Management & Operations 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 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 Host and lead sponsor monitoring visits, internal audits, and regulatory inspections as the site’s primary respondent Collaboration & Communication 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 Required Qualifications 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 Preferred Qualifications 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 Compensation & Benefits Base Salary: $72,000- $90,000 (depending on experience and qualifications) Benefits: Medical, dental, vision, PTO, and additional benefits Work Authorization Sponsorship for employment authorization may be considered on a case-by-case basis depending on the role and candidate qualifications. Equal Opportunity & Accessibility Statement We are committed to providing a workplace that is inclusive, respectful, and free from discrimination. We welcome applicants of all backgrounds and make employment decisions without regard to race, color, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, ancestry, citizenship, age, physical or mental disability, medical condition, genetic information, marital status, military or veteran status, or any other characteristic protected by California or federal law. In accordance with the California Fair Chance Act, we will consider qualified applicants with arrest and conviction records. If you require a reasonable accommodation during the application or hiring process, please contact us directly – we’re happy to help. #J-18808-Ljbffr