TEMP Clinical Trial Assistant, Senior Clinical Operations
Headquarters Location: South San Francisco, CA
Candidate Location: Hybrid
Travel Required: 5%
Reports To: Sr. Director, Clinical Operations
Department: Clinical Operations
Position Type: Temporary (6-12 months), Non-Exempt
About CytomX Therapeutics:
CytomX Therapeutics, Inc. is committed to changing the treatment of cancer with our novel Probody® therapeutic platform. Our commitment to transforming lives with safer, more effective therapies is driven by our curiosity and passion for innovation and our belief that by acting with integrity in an honest, respectful, ethical manner, we have the power to change lives. Our workplace embodies collaboration, open communication, celebrating our successes, and holding each other to the highest possible standards. CytomX has a broad pipeline, which comprises seven therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (“ADCs”), T-cell engaging bispecific antibodies (“TCBs”), and immune modulators such as cytokines and checkpoint inhibitors (“CPIs”). Learn more at www.cytomX.com.
Who You Are and What You’ll Do:
You are passionate about life sciences and making a difference to cancer patients, their families, and healthcare providers. You will be responsible for providing support to both the Clinical Operations study team members and to the cross functional execution team(s). Daily activities will focus on ensuring that the clinical trials remain on track and are consistent with related SOPs and ICH/GCP/regulatory guidelines.
Ideally the CTA will have experience with and an understanding of clinical trial conduct including study start-up and conduct processes, clinical document review and tracking, vendor access and administration support, and finally utilization of an electronic Trial Master File (eTMF) and associated document management procedures.
Job Responsibilities:
Provide support to the clinical study team with many of the tasks involved with conduct of clinical studies in compliance with CytomX processes. Liaise with contract organizations and other vendors to ensure clinical study deliverables are met (i.e., contribute to documentation, processes, and set-up activities to facilitate efficient working and effective partnerships with external groups). Draft agendas, maintain meeting minutes, create materials, liaise with meeting planners, and coordinate logistics for internal or external meetings. Track and manage inventories of clinical study suppliesAssist with study metrics and tracking of participant visits. Complete all study level submissions to central Institutional Review Boards (IRBs).Complete quarterly debarment checks for all active investigators.Contribute to the maintenance of existing eTMFs (i.e., collect documents from sites, manage and update expected document lists) and ensure inspection readiness of the eTMF through ongoing TMF completeness checks. Communicate with study investigators to provide updated study documents, weekly metrics, SUSARs and/or study status updates.
Minimum Qualifications:
A Bachelor’s degree strongly desired A minimum of 2 years industry experience working in the Pharmaceutical, Biotechnology or other related industry is required.
Preferred Qualifications:
Strong attention to detail is a must. Extensive Veeva eTMF experience is a must.Able to work in a fast-paced environment with focus on quality. Good communication skills both oral and written are a must. Good computer skills are required. Working knowledge of MS Word, Excel, and PowerPoint is required. Excellent organizational skills are required. Must have an ability to multi-task.Oncology experience is preferred.
How You Will Work:
Demonstrates collaboration and teamwork. Works well with others and understands that collaboration leads to better results. Possesses strong communication skills. Communicates clearly, concisely, and professionally. Listens actively to build understanding.Exhibits strong interpersonal skills and self-awareness. Builds and cultivates strong and enduring relationships with others. Acts with humility and understands own strengths and weaknesses. Shows continuous improvement and a commitment to self-management and development. Operates with a continuous improvement mindset and continuously seeks to expand own knowledge and capabilities. Demonstrates a patient focus. Puts the patient first in actions and decisions taken.
Compensation, Benefits, and So Much More
The expected salary range for this role based on the primary location for this position in California is starting at $45.00 per hour. Offer amounts are determined by factors such as experience, qualifications, geographic location, and other job-related factors permitted by law.A great environment where we work collaboratively, leverage each other’s strengths, and work toward a shared vision with our common goals of doing the best thing for patients. A robust and enduring approach to your development and career growth fueled by a strong learning curriculum and career guidance that helps you understand how you can grow your career at CytomX. A robust and highly competitive total rewards program that helps you achieve your compensation goals while supporting a great work / life balance.
Conditions of Employment
Background investigations are required for all positions at CytomX, consistent with applicable law.
CytomX’s Commitment to Diversity, Equity, Inclusion, and Belonging (DEIB)
CytomX believes that DEIB helps drive our success, and we encourage candidates from all identities, backgrounds, and abilities to apply. We are an equal opportunity employer committed to building an inclusive, innovative work environment with employees who reflect our values and ultimately, serve our patients. Therefore, in all aspects of the employment process, we provide employment opportunities to all qualified applicants without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity or expression, pregnancy, medical condition related to pregnancy, creed, ancestry, national origin, marital status, genetic information, or military status, or any other protected status in accordance with applicable law.
Further, we are committed to the full inclusion of all qualified individuals. As part of this commitment, we (and the agencies we work with) will assist individuals who have a disability with any reasonable accommodation requests related to employment, including completing the application process, interviewing, completing any pre-employment testing, participating in the employee selection process, and/or to perform essential job functions where the requested accommodation does not impose an undue hardship. If you have a disability and require reasonable accommodation, or need other assistance in applying for or interviewing for this position, please direct your inquiries to Human Resources, at [email protected]
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