Arsenal Biosciences
Clinical Trial Management Associate (24006-B-615-MED)
Arsenal Biosciences, South San Francisco, California, us, 94083
Clinical Trial Management Associate (24006-B-615-MED)
Arsenal Biosciences Inc. is a clinical stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors. We are seeking a talented and experienced Clinical Trial Management Associate to work hybrid or remotely based in our South San Francisco office.ArsenalBio’s mission and purpose is very clear: defeat cancer. With our programmable and computationally driven approach, our team is engineering medicines with the goal to attack cancer’s inherent multifaceted nature and overcome the challenges of addressing solid tumors with cell therapy.WHAT YOU’LL 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.WHO YOU ARE:
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.Ability to deal with time demands, incomplete information, or unexpected events.Must display strong analytical and problem-solving skills.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.BENEFITS AND PAY
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.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.
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Arsenal Biosciences Inc. is a clinical stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors. We are seeking a talented and experienced Clinical Trial Management Associate to work hybrid or remotely based in our South San Francisco office.ArsenalBio’s mission and purpose is very clear: defeat cancer. With our programmable and computationally driven approach, our team is engineering medicines with the goal to attack cancer’s inherent multifaceted nature and overcome the challenges of addressing solid tumors with cell therapy.WHAT YOU’LL 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.WHO YOU ARE:
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.Ability to deal with time demands, incomplete information, or unexpected events.Must display strong analytical and problem-solving skills.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.BENEFITS AND PAY
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.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.
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