Job description
POSITION SUMMARY
Reporting to the Executive Director, Clinical Operations, CARGO is hiring 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 Mateo, CA.
WHAT YOU’LL DO AT CARGO THERAPEUTICS
- Support one or more study execution team (SETs), including scheduling meetings, distributing agendas, rooms, participants, and meeting minutes
- Document outstanding action items with expected completion dates and responsible individuals
- Support SET risk management discussions, follow-up and documentation
- Track and maintain study information and report on study progress as well as 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 the European Investigators (If applicable) and site staff and ensure our sites get the support they need
- 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
- Creating and managing trackers and logs for oversight of clinical trials
- Ensuring a high-quality filing structure and archiving of trial documents
THE RIGHT STUFF: Required Experience & Qualifications
- Bachelor’s Degree in health care, life sciences or related field
- 2+ year’s 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 the company
- 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 & detail oriented
PAY RANGE*
The combined pay range for the Clinical Trial Associate is from $100,000 - $137,200. 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 is engineering best-in-class CAR T-cell therapy to overcome resistance to cancer treatment and address barriers to access so that more patients may benefit from potentially curative therapies. CARGO is on a mission to outsmart cancer by advancing a new generation of best-in-class chimeric antigen receptor (CAR) T-cell therapies. Despite advances made by commercially available autologous CARs, these treatments are curative for fewer than half of all cancer patients. In addition, far too many patients are unable to access these potentially curative therapies due to other challenges, including manufacturing, supply constraints, slow turnaround time and reimbursement hurdles. The team at CARGO is intensely focused on pursuing novel solutions to achieve better cancer treatment outcomes and experiences.
Our founders are pioneers and world experts in CAR T cell therapy, and we have built a team with experience and success developing, manufacturing, launching and commercializing oncology and cell therapy products. CARGO Therapeutics colleagues share a passion to help others thrive. We are tenacious in the relentless pursuit of our mission, and we innovate to change the game for the patients we serve.
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 requires 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.
offroadmanagementgroup.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, offroadmanagementgroup.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, offroadmanagementgroup.com is the ideal place to find your next job.