Remote Clinical Trial Management Associate

Summary

Join a clinical stage programmable cell therapy company as a Clinical Trial Management Associate and work hybrid or remotely based in our South San Francisco office. The ideal candidate will have experience in oncology clinical trial management, knowledge of transplant patient care and apheresis collection, and strong analytical and problem-solving skills.

Requirements

• BS/BA in nursing, science or health-related field with 2+ years experience of related oncology clinical trial management experience
• Competent knowledge of transplant patient care and apheresis collection is a plus
• Experience with CRO/Vendor oversight preferred
• Clinical research knowledge and cross-functional understanding of the clinical trial methodology
• Willing to travel to clinical sites as needed
• Willing to travel to the South San Francisco office as required
• Ability to deal with time demands, incomplete information, or unexpected events
• Must display strong analytical and problem-solving skills
• Attention to detail required
• Outstanding organizational skills with the ability to multitask and prioritize
• Excellent interpersonal, verbal, and written communication skills are essential to working in a matrix team
• Creative and innovative mindset to approach novel problem statements
• Willingness to learn and adapt to new technologies
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities

Responsibilities

• Serves as a primary liaison and clinical trial resource for the screening and enrollment of clinical trial participants
• Proactively communicates with site research staff, vendors, and technical operations to schedule and coordinate the “cell journey” activities as well as initiation/completion of study treatment and subsequent patient visits
• Manage all operational aspects of the assigned clinical trial(s) of the investigational product cell journey process by liaising with investigative sites and supply chain to support activities involved in the cell journey
• Manage the biospecimen sample collection per protocol and assist with central lab vendor activities
• Work cross-functionally to assist in implementing regulatory and compliance efforts regarding the collection of clinical samples and patient cells, including HIPAA requirements, privacy policies, and chain-of-custody
• Contribute to the review of consent form language for consistency across protocols and alignment with biospecimen samples and study investigational product storage and retention policies
• Responsible for filing necessary documents in the electronic trial master file (eTMF), and supporting regular cross-functional reviews of the eTMF
• Assist in the creation of training slides and lead training sessions for CRO or investigative sites
• Prepares metrics and updates for management as assigned. Proactively identifies potential study issues/risks and recommends/implements solutions
• Works with multiple contract research organizations and vendors to communicate detailed timelines and ensure that performance expectations are met while providing management and oversight as appropriate
• Participates in the development, review and implementation of departmental SOPs and processes
• Support other studies as required

Benefits

• Medical, dental, and vision as well as mental health resources, virtual and telehealth options, coaching, infertility treatment, parental leave and health savings accounts
• Flexible work schedules and flexible time off
• Two extra “Arsenal Days of Rest” every quarter for employees to recharge