Job Title: Clinical Researcher Associate
Location: San Diego, CA; Hybrid
Contract length: 6 months
Schedule: Full-time, 40 hrs per week
Pay: $45/hr to $50/hr, DOE

Position Overview:
The primary role of Clinical Research Associate is to support the planning, coordination, and execution of clinical research projects including multisite clinical studies, with responsibilities across study operations, EDC monitoring, site coordination, documentation, and cross-functional study support.

Key Responsibilities:

• Support study planning, start-up, execution, monitoring, and closeout activities across one or more clinical study sites.
• Coordinate day-to-day study operations with internal teams, clinical sites, vendors, CROs, and contractors, including meeting support.
• Conduct assigned EDC monitoring and centralized data review activities, including CRF review, query management, missing data follow-up, data reconciliation, and documentation of findings.
• Maintain study trackers, metrics, dashboards, screening and enrollment reports, query reports, timelines, and study summaries to support operational oversight and leadership updates.
• Support preparation and maintenance of study documents, including protocols, amendments, informed consent forms, CRFs, source documents, training materials, newsletters, and study reports.
• Collect, track, file, and reconcile Trial Master File and site regulatory documents to support inspection readiness.
• Support preparation, tracking, and submissions to IRB and regulatory documentation, as assigned.
• Assist the medical affairs team with preparing for audits and inspections, including document review, tracking, and follow-up on assigned action items.
• Track enrollment, retention, visit completion, study supplies, device accountability, protocol deviations, adverse events, technical observations/device deficiencies, audit findings, and other study issues.
• Maintain and update research agreement and budget/invoice tracking.
• Support budget, contract, vendor, regulatory submission, clinicaltrials.gov publication, and evidence-generation activities through documentation, coordination, reporting, and follow-up.
• Coordinate ordering, shipment, tracking, and reconciliation of study supplies and equipment, as applicable.
• Support approved recruitment activities, including recruitment campaigns coordination, prescreening activities, participant follow up and scheduling appointments.
• Support patient visits as assigned, including visit preparation, documentation, data entry, and follow-up in accordance with the protocol and study procedures.
• Perform assigned responsibilities in accordance with Good Clinical Practice, 
• All listed duties, requirements and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodation for additional tasks and responsibilities.

• Education and Experience: 
• Required
  • Bachelor's degree in life sciences, health sciences, nursing, public health, or related field.
  • Minimum of 2 years of experience, in clinical study support as a Clinical Research Associate (CRA) or Clinical Research Coordinator; equivalent combination of education and experience will be considered
  • Experience with EDC systems, data review, query management, study trackers, and clinical study documentation.
  • Understanding of Good Clinical Practice, informed consent, protocol deviations, adverse event documentation, Trial Master File requirements, and clinical monitoring processes.
  • Experience supporting site start-up, study coordination, enrollment tracking, site communication, and study closeout activities preferred
• Desirable
  • CRA certification preferred (such as CCRC, CCRA, or CCRP)
  • Current GCP certification preferred  
  • Medical device study experience and/or clinical experience in healthcare preferred
  • Experience and/or knowledge about the practice of sleep and respiratory medicine, including RT or RPSGT, is a plus
• Computer Skills 
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint, Visio or equivalent flowcharting software, and Outlook)
  • Ability to use approved digital and AI-enabled tools to support documentation and meeting summaries, in accordance with company policies and data privacy requirements.
• Qualifications
  • Strong analytical, organizational, and communication skills
  • Strong attention to detail, organization, documentation skills, and ability to manage multiple study tasks across sites
  • Motivated, professional self-starter who can work well independently as well as in a team environment
  • Must have a strong work ethic, team-orientation and integrity
• Work Environment 
  • Position functions in a standard office environment and requires the ability to travel to clinical sites (approximately 30%)
  • Located in San Diego area