Job Description

Company Description

SOLVD Health is dedicated to preventing disease by making actionable and contextual health information accessible to everyone through Patient Intelligence. The company believes in bringing about real, lasting change in patients' lives by addressing the biggest challenges in healthcare.

Role Description

This is a full-time hybrid role for a Clinical Research Associate at SOLVD Health. The Clinical Research Associate will be responsible for protocol management, conducting clinical trials, overseeing research activities, and managing clinical operations. The role is located in the San Diego / Carlsbad, CA area with the option for some remote work.

Qualifications

• Experience in Protocol management, Clinical Research Associate, and Clinical Trials
• Strong research skills
• Knowledge of Clinical Operations, GCP, FDA regulations, ICH guidelines, and clinical trial processes
• Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS)
• Excellent organizational and time management skills
• Attention to detail and accuracy
• Ability to work independently and collaboratively
• Experience in the healthcare or medical field
• Bachelor's or Master's degree in a related field (e.g., Life Sciences, Nursing, Pharmacology)

Preferred:

• Advanced degree (MS, MPH, or PhD) in a relevant field
• Experience working with biotechnology, pharmaceutical, or CRO organizations
• Previous experience in oncology, rare diseases, or genetic studies is a plus
• Clinical Research Certification (CCRA, CCRP, or equivalent)

Job Functions

Clinical Trial Execution & Management

• Assist in the planning, initiation, and execution of clinical trials in accordance with Good Clinical Practice (GCP), FDA regulations, and ICH guidelines.
• Support the development of study protocols, informed consent documents, case report forms (CRFs), and other essential study documents.
• Coordinate site selection, feasibility assessments, and initiation visits.
• Monitor clinical trial sites to ensure adherence to study protocols and compliance with regulatory requirements.
• Assist in vendor and CRO management, ensuring timely study deliverables.
• Oversee clinical study sample tracking and storage in collaboration with sites, labs, and vendors.

Regulatory & Compliance

• Maintain accurate and complete Trial Master File (TMF) documentation.
• Support Institutional Review Board (IRB)/Ethics Committee submissions and approvals.
• Ensure study records, data integrity, and sample management comply with regulatory and sponsor requirements.

Data Collection & Quality Assurance

• Review site data to ensure accuracy, completeness, and compliance with study protocols.
• Assist in query resolution and data reconciliation efforts.
• Participate in risk-based monitoring and site management strategies.

Cross-functional Collaboration

• Communicate with study sites, investigators, and sponsors to provide trial updates and resolve issues.
• Collaborate with Clinical Operations, Regulatory Affairs, Data Management, and Laboratory Teams to ensure trial success.
• Assist in training site staff on study procedures and protocol compliance.

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