What are the responsibilities and job description for the Clinical Advisor position at Axle Informatics?
Overview
Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH). Overview Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Clinical Advisor to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS) Therapeutics Research Program (TRP). Responsibilities- Lead the implementation of operational plans for various aspects of the ongoing COVID-19 treatment studies and research efforts, including timeline, key milestones, resources needed and budget. The ACTIV 2 study is the U.S. Government’s premier effort to develop data on promising therapies for outpatients suffering from COVID-19 disease. The study is a complex platform study, capable of testing multiple investigational products simultaneously. It is an adaptive design spanning traditional phase 2 and phase 3 of clinical development. It is being conducted under the auspices of the NIH, and the NIH-funded AIDS Clinical Trial Group (ACTG). The ACTIV-2d study is a collaborative effort with Shionogi testing the promising compound ensitrelvir in global phase 3 study.
- Work with study partners, clinical project managers, and DAIDS leads:
- Oversee efforts to appropriately close out the ACTIV-2 trial including working with TRP leadership to prepare for potential audits.
- Work with TRP leadership to ensure high quality, rapid enrollment and implementation of the ACTIV-2d trial.
- Work with DAIDS laboratory leads and support the DAIDS Clinical Oversight Team to ensure laboratory quality and maintenance/access to data and sample repositories for exploratory research.
- Support efforts to overcome laboratory related hurdles such as stock outs.
- Support coordination efforts to recruit participants into the trial including global trial and site-specific recruitment plans, media and outreach programs and vendor programs.
- Support other COVID-19 related research efforts.
- As needed, review TRP and DAIDS processes (or lead a team that reviews the processes) that relate to or impact any of the above items and work with implementing partners to revise SOPs, process pathways, and implementation plans to effect more efficient or rapid outcomes.
- Create and oversee the execution of a study risk management plan. Proactively resolve risks to operational delivery.
- Support meeting documentation and follow-up action items.
- Facilitate reporting of study status to key stakeholders involved with COVID-19 trials.
- B.S./B.A. degree in a related field.
- Minimum of 10 years of related experience is required.
- 100% Medical, Dental & Vision premium coverage for Employees
- Paid Time Off (Including Holidays)
- Employee Referral Bonus
- 401K Match
- Tuition reimbursement and professional development opportunities
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
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