Sr. Clinical Research Coordinator (Carlsbad, CA)

Our Mission: Improving Lives by Providing Advanced Therapeutic Options

Our Vision: Creating the Absolute Best Patient-Physician Experience in Clinical Research

Our Values: Compassion:

• We prioritizethe patient-physicianrelationship, ensuring every interaction is service-oriented and patient-centered.
• Urgency:
• We work hard and practice selflessness, acting swiftly and decisively to meet the needs of our patients, partners, and colleagues.
• Solution Orientation:
• We embrace challenges with a positive mindset, communicate directly, andidentifyand implement effective solutions with efficiency.
• Excellence:
• We insist on excellence, holding ourselves accountable and empowering each other to deliver best-in-class service while maintaining the highest ethical and scientific standards.

Role: Senior Clinical Research Coordinator

Company: Profound Research

Role & Responsibilities: Maintain site compliance for all clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements. Maintain working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s).Complete all relevant Profound Research required training, including but not limited to ICH-GCP certification and IATA certification in a timely manner. Lead, implement and coordinate duties for assigned clinical trials including but not limited to study start up, vendor management, subject recruitment, source document review and completion, protocol training, collection of regulatory documents, participant visits, timely data collection and documentation, management and reporting of adverse events, serious adverse events, and deviations, and monitoring visits and follow up. Ensure the creation, collection, and submission of regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations, and IRB requirements. Create patient recruitment and study execution strategies are implemented so that timelines and recruitment expectations are met. Ensure good documentation practices are applied by all team members when collecting, maintaining, and correcting study data and required records of clinical trial activity including but not limited to source documentation, case report forms, queries, drug dispensation records, and regulatory forms. Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors. Mentor and train staff in the conduct of clinical trials, protocol requirements, communication, and trial management skills Collect and account for supplies from sponsors such as lab kits, ancillary supplies, and investigational products. Other duties as assigned.