Clinical Trial Management Associate (23098-R-615-MED)
South San Francisco, CA, USA
Posted on Wednesday, October 18, 2023
Arsenal Bio, a privately held programmable cell therapy company engineering advanced CAR T therapies for solid tumors, is seeking a talented Clinical Trial Management Associate (CTMA) to work hybrid - South San Francisco.
ArsenalBio’s mission is to develop efficacious and safe cellular therapies for patients with chronic diseases, initially cancer. Our products are being designed to herald the transition of adoptive cell therapy from a hospital based treatment to outpatient therapy, like most other cancer treatments.
Clinical Operations facilitates excellence in clinical trial execution and partners with Technical Operations to ensure drug product quality and delivery. The Clinical Trials Management Associate will work closely with Technical Operations to ensure drug product quality and delivery, Translational Sciences to ensure timely site biomarker sample collection and shipments, and support the clinical operations team with TMF filing and other duties as assigned. The candidate must be knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines. This role will require an ability to operate in a fast-paced, highly dynamic environment within a matrix team and have partnerships that include both internal and external stakeholders.
What You Will Do:
- 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
What Will You Bring:
- Your whole self
- 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
What We Will Offer You:
ArsenalBio has a generous and comprehensive benefits package that includes but is not limited to medical, dental, and vision as well as mental health resources, virtual and telehealth options, coaching, infertility treatment, parental leave and health savings accounts. We also offer flexible work schedules and flexible time off, which includes two extra “Arsenal Days of Rest” every quarter for employees to recharge.
We have a robust mentorship program, and comprehensive development tools to help employees take control of their career paths and grow into their best selves. ArsenalBio believes in investing in the well-being of our employees - both at work and at home, as they are our greatest asset. They bring scientific talents in molecular biology, immunology, pharmacology, protein chemistry, computational biology, automation, genome engineering, software and other fields to make the future happen now.
We are committed to hiring the best talent from diverse backgrounds. A diverse workforce engenders richness of thought, creativity and discovery. We invite individuals who embrace intellectual achievement to bring their unique personal and professional journeys and together we will build transformative cell therapies for cancer patients.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
The estimated base salary offer for the preferred primary location of San Francisco Bay area ranges from $93,500–$114,500. Salary ranges for other locations may vary from this range. Base pay offered may vary depending on job related knowledge, experience, education, and location. In addition to these factors, we believe in the importance of pay equity and consider internal equity of our current employees as part of any final offer.
To all recruitment agencies: ArsenalBio does not accept agency resumes. Please do not forward resumes to our jobs alias, or ArsenalBio employees. ArsenalBio is not responsible for any fees related to unsolicited resumes.