Clinical Research Associate II - Oncology

Systimmune • Los Angeles, CA

1d • $90,000 - $115,000

About The Position

SystImmune is seeking an experienced Clinical Research Associate II to support its clinical trials. The role manages and oversees assigned clinical study sites to ensure data quality and patient safety in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs. The successful candidate is self-motivated, independent, organized, able to multitask, and comfortable working in a small team while adjusting to changing project and corporate priorities.

Requirements

• Bachelor’s degree in health science or a related field.
• At least 2 years of experience independently monitoring oncology trials and conducting on-site and remote monitoring visits.
• Excellent verbal and written communication skills.
• Excellent organizational, multitasking, and time-management skills.
• Demonstrated experience developing and maintaining site relationships and securing compliance.
• Working knowledge of International Conference on Harmonization Good Clinical Practice guidelines.
• Experience with Microsoft Office products (Word, Excel, PowerPoint, SharePoint, and Teams) and clinical trial systems such as CTMS, EDC, and eTMF.
• Ability to travel as required (50–75%).

Responsibilities

• Perform Site Evaluation Visits, Site Initiation Visits, interim monitoring visits, and Close Out Visits.
• Prepare the study reference manual and coordinate with the CRO team, including central and specialty labs and vendors, to prepare and deliver study materials to investigator sites.
• Ensure investigator sites have met contractual and regulatory requirements for site initiation and first release of study drug.
• Assist in developing study and program plans, such as the Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, and Safety Management Plan.
• Manage patient recruitment strategies, identify recruitment barriers, and propose solutions such as site webinars and newsletters.
• Monitor recruitment, data quality, and patient safety on site and remotely through EDC systems and direct site communication.
• Work with study site personnel to ensure timely, accurate eCRF entry and resolution of data queries.
• Maintain project files, including ethics committee approvals, investigator and study personnel CVs, clinical investigator brochures, protocols, case report form instructions, consent documents, clinical-trial material shipping orders, meeting attendance documentation, letters of agreement, lab reference ranges, and site correspondence.
• Identify and complete follow-up of SAEs at study sites.
• Assist with data listings, data coding, patient profile reviews, database lock, and site close-out activities.
• Ensure timely and appropriate submission of documents to the Trial Master File.
• Perform investigational product inventory and reconciliation; review storage and security; verify dispensing and administration according to protocol; and verify issues or risks related to blinded or randomized investigational product information.

Benefits

• 100% paid employee premiums for medical, dental, and vision insurance.
• Short-term and long-term disability coverage.
• 401(k) plan with a 50% company match of up to 3% and a five-year vesting schedule.
• 15 PTO days per year.
• Sick leave.
• 11 paid holidays.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level