Senior Clinical Research Associate, Clinical Operations
Senior Clinical Research Associate, Clinical Operations
At Arch Oncology, we are aiming high to discover and develop new antibody therapeutics to treat patients living with cancer. We are committed to advancing antibodies with best-in-class potential.
Our next-generation anti-CD47 antibodies are highly differentiated, with the potential to improve upon the safety and efficacy profile relative to other agents in this class. Our antibodies work by blocking the “don’t eat me” signal, the standard mechanism of anti-CD47 antibodies. Beyond blocking this signal, our antibodies also directly kill tumor cells. Importantly, our antibodies bind preferentially to tumor cells, instead of to normal cells, and bind even more potently to tumors in their acidic microenvironment (low pH).
Expanding our fight against cancer, we are advancing our lead anti-CD47 antibody AO-176 into clinical development for the treatment of patients with solid tumors.
We are aiming high in our fight against cancer. We are a team of highly experienced and driven professionals who are committed to excellence in all that we do. Our leadership team has successfully developed new drugs before. We know what we need to do to collaborate and execute to get the job done.
If you share this commitment and want to work with a team that is focused on helping patients, come aim high with us and apply.
At Arch Oncology, we have two bases. Our headquarters is in Brisbane, CA, a gateway of biotechnology innovation, and our scientific research laboratory is in St. Louis, MO, home of the Gateway Arch.
This position will be full time remote, home based with occasional travel.
Associate Director, Clinical Operations or Clinical Trial Manager
- Support in the oversight and management of key study parameters including study start-up activities, development of study plans, vendors, drug inventory, lab supplies, non-clinical study supplies, lab sample management, screening and enrollment activity and proactively identify solutions within the study team as required
- Assist in study start-up through closeout activities such as study feasibility, site selection, site initiation, and site and study closure
- Develop and conduct CRA and site training of protocol requirements at site initiation visits and/or Investigator Meetings
- Reviews and/or author informed consent forms, monitoring plans, training materials, site study manuals, and related study documentation
- Assist with the review of clinical protocols, case report forms, study newletters, vendor specification documents, participate in user acceptance testing for eCRFs and recommend operational changes as required
- In collaboration with Translational Medicine Ops; assist in the review of Laboratory related documents and processes, tracking of lab supplies and assisting with lab sample discrepancies
- Oversee planning of Investigators Meetings, as required.
- Conduct co-monitoring and/or oversight visits as needed
- Manage all study supply requirements (storage, distribution, site inventory, etc.)
- Assist with the projection and management of clinical supply inventory.
- Provide project administrative support including maintenance of meeting documentation (eg. Meeting minutes), study documentation, trip reports, monthly status reports (e.g., enrollment, adverse events, budget, etc.) including assisting with oversight of the Trial Master File (TMF).
- Track, process and manage vendor invoices in support of study financial tracking.
- Assist in the creation of project tools, tracking tools, etc. to report and oversee study specific metrics as needed
- Demonstrated clinical research experience, with in-depth knowledge of clinical oncology, including working knowledge of good clinical practices for clinical research.
- Ability to work independently as well as collaboratively in an efficient manner
- Skillful in prioritizing workflow with different demands to meet deadlines in an accurate and timely manner
- Demonstrated ability to attain and maintain a working knowledge of Good Clinical Practices and applicable Standard Operating Procedures
- Can-do mindset, with ability to build esprit de corps with team members and build effective working relationships across all levels of the company
EDUCATION AND EXPERIENCE:
- Bachelor’s level degree in life sciences, pharmacy or nursing; RN preferred
- Prior related clinical research experience of 5-8 years in the Pharma/Biotechnology
- Oncology experience required with Global experience a plus
- Experience managing outside vendors, e.g., CROs and labs
- Able to deal with time demands and work independently and collaboratively.
- Knowledge of the principles and practices of basic computer applications used in general office setting, including word processing, spreadsheet, database management, presentation software, and internet search engines
- Capabilities with Microsoft PowerPoint, Word, Excel, and Project desired.
- Basic math and standard business level English grammar and usage.
- Able to travel approximately, as necessary
- Knowledge of clinical research operations, including interpretation and implementation of cGCP, FDA regulations, and ICH guidelines is required. Global (Ex-US) regulatory experience a plus
Arch Oncology offers a generous benefit package including medical, dental, vision, and disability insurance, as well as paid time off and a 401k plan.
Arch Oncology is an Equal Opportunity Employer and does not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.