Clinical Trial Logistics Associate (23007-B-615-MED)

South San Francisco

Medical Sciences /

Full-Time /

Remote

ArsenalBio, a privately held, clinical-stage programmable cell therapy company engineering advanced CAR T therapies for solid tumors, is seeking a talented Clinical Trials Logistics Associate to work Remote in South San Francisco.

ArsenalBio’s mission is to develop efficacious and safe cellular therapies for patients with chronic

diseases, initially cancer. With our programmable and computationally driven approach, our team is engineering living medicines to attack cancer’s inherent multi-faceted nature and overcome the challenges of addressing solid tumors with cell therapy.

Driven by a collective of diverse experts across immunology, synthetic biology, molecular biology, automation and computational biology, we are united in purpose to deliver radical breakthroughs for people with cancer, and prioritize the team’s outcomes over individual goals to achieve our company mission – together.

Clinical Operations facilitates excellence in clinical trial execution while partnering with various functional areas. The Clinical Trials Logistics Associate will work closely with Technical Operations to ensure drug product quality and delivery and with Translational Sciences to ensure timely site biomarker sample collection and shipments. The position will sit within Clinical Operation and will liaise with the study CRO, investigative sites, central lab(s), and internal stakeholders.

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:

Manage all operational aspects of the assigned clinical trial(s) involving the biospecimen sample collection per protocol and the investigational product cell journey process as listed in the respective sections below.
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.
Assist in the creation of training slides and lead training sessions for CRO or investigative sites.
Participate in the development, review, and implementation of departmental SOPs and processes.
Ensure the proper filing of study-related documents in the Trial Master File (TMF) and perform Quality Reviews per scheduled timelines.
Travel to the South San Francisco office as required.
Other duties as assigned.

Biospecimen Sample Logistics

Oversee site biospecimen sample routing, tracking, and query resolutions in conjunction with the CRO and the central/specialty lab(s).
Manage all aspects of the central lab vendor oversight and assist with other vendor management activities including selection, contracts review, change in scope, and invoice review.
Review and maintain study-related central lab specifications, lab manuals, flow charts, and requisition forms.
Attend central lab and specialty lab meetings as well as any study-related meetings.
Assist in ensuring the availability of clinical trial supplies related to biospecimen collection, processing, shipment, and storage in conjunction with the CRO and the Central/Specialty Lab.
Assist in reviewing clinical study protocols for sample collection requirements and alignment with lab SOW(s), study lab manuals, and relevant company policies.
Ensure that the CRO is properly tracking informed consents for clinical sample use (incl. future & unrelated research) if applicable.

Cell Journey Logistics

Support enrollment of study participants and liaise with investigative sites, supply chain, and logistics to support activities involved in the cell journey process including apheresis, shipping, processing, manufacturing and return of investigational product back to the investigative sites.
Contribute to the review of study-related manuals (e.g., Leukapheresis Reference Manual and Investigational Product Manual) and forms/documents (e.g., screening, enrollment, shipment receipt, and product destruction).
Assist with the collection of forms and surveys from the investigative sites as required by Quality to onboard and qualify a site Apheresis Center.
Work with the CRO to ensure all the appropriate manuals and study forms/documents are provided to sites at the start of the study and as versions are updated.

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
Experience managing clinical trials in cell therapy or immuno-oncology
Competent knowledge of transplant patient care and apheresis collection is a plus.
Clinical research knowledge and cross-functional understanding of the clinical trial methodology
Proficient in developing trial plans and manuals and in clinical supplies management.
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 multi-task 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.
Willing to travel to clinical sites as needed.

ArsenalBio prioritizes the providing of a safe and healthy workplace that is consistent with COVID-19 public health guidance and legal requirements. In order to protect our employees and visitors, we require all visitors (candidates) and employees to present proof of being fully vaccinated against COVID-19 when coming onsite.

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 $80,200 -$98,300

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.

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