- Support 1 or more Study Management Teams (SMTs), including scheduling meetings, distributing agendas, rooms, participants, and meeting minutes
- Document outstanding action items with expected completion dates and responsible individuals
- Support SMT risk management discussions, follow-up, and documentation
- Track and maintain study information and report on study progress; maintain and disseminate basic study tracking information including, but not limited to: visit reports, regulatory documents, site contact lists, team contact lists, and vendor lists
- Obtain, review, process, and track study related documents (CVs, FDA 1572s, lab certifications, IRB approvals, contracts, protocols, etc.) in addition to tracking and providing IRB/IEC submission documentation and other supplementary documentation, as appropriate
- Support Essential Document Packet (EDP) review and approval process
- Support Informed Consent Form (ICF) development, review and approval process
- Ensure a high-quality filing structure and archive of trial documents including maintenance and oversight on the completeness of the Trial Master File (TMF) in accordance with SOP requirements
- Support preparation of materials for investigator meetings, workshops, and study manuals
- Lead development of study newsletters
- Support onboarding of new CTA team members
- Support process improvement initiatives
- Build a strong relationship with investigators (if applicable) and site staff; ensure our sites get the support they need
- Perform study start-up activities
- Site and vendor management including oversight of preparation, shipment, and management of study supplies to sites
- Provide data management support by ensuring timely data entry and centralized data monitoring in preparation for monitoring visits
- Create and manage trackers and logs for oversight of clinical trials
- Ensure a high-quality filing structure and archival of trial documents
- Bachelor's degree in health care, life sciences or related field
- 2+ years' experience as a CTA or similar role in a biotechnology or pharmaceutical company supporting clinical trial conduct
- History of full spectrum meeting management
- Successful at maintaining study information and reporting study progress
- Excellent interpersonal, organizational, problem-solving, and written/verbal communication/influence skills
- Confidence and experience of effectively working/leading/influencing a wide variety of medical, research and administrative personnel within and outside CARGO
- Experience working with Trial Master Files and study related documentation
- Adept in Microsoft Office Suite (Excel, PowerPoint, Word, etc.)
- Proficient in problem solving and time management
- Independently motivated and detail-oriented
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clinical trial associate - San Carlos, CA, United States - Cargo Therapeutics
Description
Reporting to the VP, Clinical Operations, CARGO is seeking a Clinical Trial Associate to play a crucial part in the Study Management Team. The successful candidate will coordinate various administrative aspects of the sponsor's project management and oversight activities. The individual will partner closely with the Clinical Project Managers and Clinical Research Associates to provide administrative expertise to multiple clinical study management teams. This role will help to define and implement meaningful oversight of CROs by supporting study start-up activities, tracking study progress, overseeing the Trial Master File quality and completeness, maintaining meeting agendas and minutes, and implementing learnings/sharing knowledge with other study management teams. This team member will work with a high degree of independence and provide administrative support and guidance to help the team achieve high performance and quality project deliverables.
The role is based in San Carlos, CA.
WHAT YOU'LL DO AT CARGO THERAPEUTICS
The combined pay range for this role is $88,000 - $121,000. Title and salary will be based on our assessment of skills and experience relevant to our needs for the role.
ABOUT CARGO THERAPEUTICS
CARGO Therapeutics, Inc. is a clinical-stage biotechnology company positioned to advance next generation, potentially curative cell therapies for cancer patients. CARGO's programs, platform technologies, and manufacturing strategy are designed to directly address the limitations of approved cell therapies, including limited durability of effect, safety concerns and unreliable supply. CARGO is currently evaluating its lead program, CRG-022, an autologous CD22 chimeric antigen receptor (CAR) T-cell therapy candidate, in a potentially pivotal Phase 2 clinical trial in patients with large B-cell lymphoma (LBCL) whose disease relapsed or was refractory (R/R) to CD19 CAR T-cell therapy. CARGO also plans to evaluate CRG-022 in patients at earlier stages of disease, including LBCL and other hematologic malignancies. Beyond its lead program, CARGO is leveraging its proprietary cell engineering platform technologies to develop a pipeline of programs that incorporate multiple transgene therapeutic cargo designed to enhance CAR T-cell persistence and trafficking to tumor lesions, as well as to help safeguard against tumor resistance and T-cell exhaustion. CARGO's founders are pioneers and world-class experts in CAR T-cell therapy, and its team has significant experience and success developing, manufacturing, launching and commercializing oncology and cell therapy products. For more information, please visit the CARGO Therapeutics website at https://cargo-
Join us to help make a difference
EEO & EMPLOYMENT ELIGIBILITY
CARGO Therapeutics, Inc. is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. CARGO Therapeutics, Inc. also complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification required of applicable law.
CARGO Therapeutics requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at CARGO Therapeutics, and it applies regardless of whether the position is located at a CARGO Therapeutics site or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.
