Clinical Research Coordinator-258798

Medix™; Walnut Creek (CA); On-site; USD 60,000 - 90,000; Full time

Job summary

Medix™ is seeking a detail-oriented Clinical Research Coordinator to manage protocol-driven patient visits and drive end-to-end clinical trial operations. You will work with Principal Investigators, research teams, Sponsors, and CROs to oversee trial execution, ensure compliance, and deliver high-quality data across study phases.

The role requires conducting visits and procedures (phlebotomy, IVs, ECGs), coordinating recruitment, obtaining informed consent, and maintaining accurate eCRFs.

Qualifications

• Bachelor’s degree or commensurate hands-on clinical research experience.
• Strong knowledge of clinical trial execution, lab procedures, and eCRF reporting.
• Deep understanding of regulatory standards (ICH, FDA, GCP).
• Demonstrated critical thinking, organizational skills, and attention to detail in fast-paced environments.
• Excellent communication with PIs, research staff, CROs, sponsors, and patients.

Responsibilities

• Conduct protocol-specified visits and procedures (phlebotomy, IV, injections, ECG).
• Lead patient recruitment to meet timelines and schedule visits.
• Administer informed consent per regulatory requirements.
• Document assessments and CRFs in e-source/eCRF with source documentation.
• Monitor safety by reporting Adverse Events and escalate Serious Adverse Events within 24 hours.
• Oversee trial supply chain and inventory of investigational products and materials.
• Maintain cross-functional communication with study leads, investigators, and sponsors.
• Ensure HIPAA-compliant handling of patient data and adherence to policies.

Skills

Clinical trial execution

Regulatory standards ICH/FDA/GCP

Communication & teamwork

MS Office proficiency

HIPAA compliance awareness

Education

Bachelor’s degree in a relevant field

Tools

eCRF/eSource systems

Job description

We are seeking a detail-oriented and dedicated Clinical Research Coordinator to manage protocol-driven patient visits and drive end-to-end clinical trial operations. Working closely with Principal Investigators, research teams, Study Sponsors, and CROs, you will oversee trial execution, ensure strict regulatory compliance, and deliver high-quality data across all study phases. You will play a vital role in upholding patient safety, ethical enrollment, and accurate clinical documentation to support successful study outcomes.

Responsibilities

• Conduct protocol-specified clinical visits and diagnostic procedures, including phlebotomy, IV administration, injections, vital sign collection, and ECG/EKG assessments.
• Lead patient recruitment initiatives to ethically meet target timelines while managing subject scheduling and conducting visits according to strict protocol timelines.
• Administer informed consent processes in full compliance with federal regulations, Good Clinical Practice, and Institutional Review Board mandates.
• Document clinical assessments and trial data into e-source platforms and complete Case Report Forms (CRFs/eCRFs) while maintaining meticulous source documentation.
• Monitor patient safety by promptly identifying and reporting Adverse Events, and escalating Serious Adverse Events to sponsors within 24 hours while keeping PIs, Sub-Investigators, and leadership fully informed.
• Oversee trial supply chain and inventory, accounting for and ensuring the constant availability of investigational drugs, lab supplies, and CRFs.
• Maintain ongoing, structured communication with study leads, managers, investigators, and sponsor delegates to ensure cross-functional alignment and protocol adherence.
• Ensure absolute patient confidentiality compliant with HIPAA requirements, performing all clinical duties safely and cost-effectively in accordance with institutional policies.

Required Skills

• Bachelor’s degree in a relevant field or commensurate hands-on clinical research experience.
• Strong functional knowledge of clinical trial execution, including medical terminology, lab collection/processing/storage procedures, and electronic e-source/eCRF reporting systems.
• Deep understanding of regulatory standards, including ICH, FDA, and GCP guidelines.
• Demonstrated critical thinking, high-level organizational skills, and acute attention to detail in fast-paced clinical environments.
• Exceptional communication and interpersonal abilities to interact professionally with PIs, research staff, CROs, study sponsors, and patient populations.
• Advanced proficiency with personal computers and Microsoft Office Suite.

Preferred Skills

• 1+ years of direct experience working as a Clinical Research Coordinator.
• Practical clinical experience performing phlebotomy, IV starts, and ECG/EKG procedures.