Senior CRA - Oncology Biotech

Summary

SystImmune is seeking a Senior Clinical Research Associate (Sr. CRA) to support clinical trials. Key responsibilities include site evaluation, data collection, and patient safety oversight.

Essential Duties and Responsibilities

• Perform Site Evaluation Visits, Site Initiation Visits, Interim Monitoring Visits, and Close Out Visits
• Ensure investigator sites meet contractual and regulatory requirements for site initiation and first release of study drug
• Affirmatively assist in the collection of key documents to enable site activation
• Support the development of study/program plans and/or SOP updates as directed by the Clinical Project Manager
• Manage patient recruitment strategies, proactively addressing barriers to recruitment
• Maintain oversight of recruitment, data quality, and patient safety both on-site and remotely
• Liaise with study site personnel to ensure timely and accurate data entry into eCRFs
• Manage project files including ethics committee approvals, investigator CVs, protocols, CRFs, consent documents, and IP inventory
• Identify and address Serious Adverse Events (SAEs) at study sites
• Ensure timely submission of documents to the Trial Master File
• Manage investigational product (IP) inventory, reconciling and reviewing storage and security
• Verify IP dispensation and administration according to protocol
• Verify issues or risks associated with blinded or randomized information related to IP

Required Skills & Qualifications

• Bachelor’s degree in health science or related field
• 5+ years of independent on-site and remote monitoring experience in oncology trials
• Excellent verbal and written communication skills
• Strong organizational, multi-tasking, and time management skills
• Demonstrated experience building 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, Teams)
• Experience with clinical trial systems (CTMS, EDC, eTMF)
• Ability to travel as required (50-75%)

Benefits

SystImmune offers a comprehensive benefits package including:

• 100% paid employee premiums for medical/dental/vision, STD, LTD, a 401(k) plan with a 50% company match of up to 3%, and a vesting schedule of only 5 years
• 15 PTO days per year, sick leave, and 11 paid holidays