Sr. Public Administration Analyst - Clinical Research

Ampcus - Los Angeles, CA

Full-time - Mid Level

Los Angeles, CA

Professional, Scientific, and Technical Services

About the position

The Department of Medicine Clinical Trial Program is seeking a skilled Senior Clinical Research Associate to oversee, manage, and participate in research activities. This role is critical in ensuring compliance with ICH/Good Clinical Practices (GCP), governing standard operating procedures (SOPs), and clinical study protocols. The Senior Clinical Research Associate will be responsible for research assessment and patient intervention under the supervision of the Principal Investigator. This position requires a proactive approach to managing clinical research sites and ensuring that all activities align with regulatory compliance standards. In addition to overseeing compliance, the Senior Clinical Research Associate will play a key role in patient recruitment and enrollment, data collection, and maintaining accurate research chart documentation. Quality assurance is a significant aspect of this role, as is the preparation of reports and the dissemination of protocol information to healthcare professionals, patients, and their families. The position may involve assignments from Senior Management, which can change as needed to ensure that studies and patient care needs are met in a timely manner. The role may also require travel to other locations as necessary to fulfill job responsibilities. The ideal candidate will be a multi-tasked individual with a minimum of 5 years of experience in a clinical research coordinator role, possessing a college degree in medicine, science, health, or a related field. The candidate should demonstrate the ability to manage research activities effectively, ensuring the collection of accurate clinical data within specified timelines. Knowledge of ICG GCP guidelines and the ability to review and evaluate medical data in accordance with local laws and regulations are essential. Experience in selecting and managing vendors or CROs, as well as tracking the progress of clinical studies concerning budget, milestones, and deadlines, is also required. The candidate should be adept at recruiting and enrolling patients who meet eligibility criteria, scheduling, and completing case report forms (CRFs). Problem-solving skills, the ability to prioritize multiple tasks, and proactive planning are crucial for success in this dynamic team environment. Participation in study audits may also be required as part of the role.

Responsibilities

• Oversee and manage clinical research activities to ensure compliance with ICH/GCP and governing SOPs.
• Conduct research assessments and patient interventions under the supervision of the Principal Investigator.
• Ensure regulatory compliance and maintain accurate research chart documentation.
• Recruit and enroll patients who meet eligibility criteria and manage scheduling and CRF completion.
• Track progress of clinical studies regarding budget, milestones, and deadlines.
• Participate in study audits as applicable.
• Prepare reports and disseminate protocol information to healthcare professionals, patients, and their families.

Requirements

• Minimum 5 years of experience in a clinical research coordinator role.
• College degree in medicine, science, health, or equivalent.
• Knowledge of ICG GCP guidelines and local laws and regulations.
• Experience in selection and management of vendors/CROs (Central Lab, IVRS, EDC).
• Ability to manage research activities to ensure accurate clinical data collection within timelines.
• Strong problem-solving skills and ability to prioritize multiple tasks.

Nice-to-haves

• Experience as a Study Coordinator, Clinical Manager, Clinical Research Associate, or Senior Clinical Research Associate.
• Strong analytical and organizational skills.
• Excellent interpersonal communication and multitasking abilities.