Clinical Advisor

(ID: 2024-5966)

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).

Benefits

• 100% Medical, Dental & Vision 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)
  

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) , The Division of AIDS (DAIDS), Therapeutics Research Program (TRP).

Technical Requirements

• Lead the creation, implementation and appropriate closeout of an overall operational plan for one or more treatment studies including COVID-19 trials. Activities may include but not limited to timeline, key milestones, resources needed and budget.
• Assess the operational feasibility and resource considerations of new entrants to said trials.
• Work through established contract resource organizations and with the sponsor, networks and company partners:
• Create a global site/country strategy
• Oversee the execution of that strategy including site selection including feasibility, qualification and pre-study assessment
• Oversee site activation including, the provision of investigational product, non-IP clinical supplies and laboratory materials; the completion of required regulatory documentation and the granting of needed systems access.
• Coordinate efforts to recruit participants into the trial including global trial and site specific recruitment plans, media and outreach programs and vendor programs.
• Oversee the execution of the study monitoring and oversight plan. Ensure site productivity and quality issues are actively managed.
• Oversee the executions of the data management plan. Ensure that queries are resolved and database closure occurs on time.
• Oversee the study close-out plan.
• As needed, review 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 in the US Government including NIH, the ACTG, and other partners/collaborators.
  

Specific Qualifications

• B.S./B.A.degree in a related field.
• Minimum of ten (10) years of related experience.
  
  

The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.

Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com

Disclaimer:The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.