Clinical Research Associate
Medeor Therapeutics is a private, clinical-stage biotechnology company dedicated to the discovery, development and commercialization of transformative and personalized cellular immunotherapies to improve outcomes in organ transplant recipients. We are currently seeking a qualified, highly motivated, experienced individual for the position of Clinical Research Associate (CRA). The position reports to the Sr. Clinical Trial Manager. The location of the position is in San Mateo, California.
The CRA will support clinical trial management with the implementation and conduct of clinical trials, focusing on the areas of trial planning, enrollment, site monitoring, data quality, and study reporting. Responsibilities include assisting in trial set-up, execution, oversight and reporting for clinical studies while ensuring the trials are conducted in compliance with the protocol, ICH/GCP, and applicable regulatory requirements. The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job.
Essential Duties & Responsibilities
• Plans and assists study start-up activities (eg, creation and/or review of Laboratory Manual, Site Initiation Presentations, CRF Completion Guidelines and various forms, study tracking and management documents)
• Assists with oversight of CRO, including project tracking of subject and site information, and helps prepare metrics and updates for management
• Manages and files documents within electronic and/or paper Trial Master File
• Assists in review of study documents for accuracy and completeness (including but not limited to: protocols, informed consent forms, study materials, etc.)
• Performs or oversees CRO pre-site selection and site initiation, as well as interim, close-out, and co-monitoring visits to ensure compliance with protocol and regulatory requirements and to assure good site performance
• Participates in the development and review of departmental SOPs and processes
• Overnight travel may be required (approximately 25%)
• Reviews and manages monitoring visit reports
• May be assigned other projects and duties as required
• At least 2+ years of clinical trial (Phase 2/3) management experience in the pharmaceutical or biotechnology industry.
• BS or BA in a relevant scientific discipline.
• Experience in cell immunotherapy is desirable. Experience in transplantation is a plus.
• Demonstrates a positive, ‘can-do’ attitude. Strong oral and written communicator, detail-oriented with a commitment to accuracy.
• Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
• Ability to multi-task and shift priorities quickly while working under tight deadlines.
• Skilled in developing collaborative internal and external relationships.
• Knowledge of FDA Regulations, ICH Guidelines, and GCP governing the conduct of clinical trials.
• Strong computer experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint)