Clinical Advisor

2 weeks ago

Rockville, United States Axle Full time
Job DescriptionJob Description

(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.

  • Clinical Advisor

    1 week ago

    Rockville, United States GAP Solutions, Inc. (GAPSI) Full time

    Position Objective: Provide services as a Clinical Advisor in support of the overall functions of the Division of AIDS, Office of Clinical Site Oversite (OCSO), Asia and the Americas Branch (AAB) within the National Institute of Allergy and Infectious Diseases (NIAID). Duties and Responsibilities: Implement and coordinate a range of individual clinical...

  • Clinical Advisor

    4 weeks ago

    Rockville, United States GAP Solutions Inc Full time

    Position Objective: Provide services as a Clinical Advisor in support of the overall functions of the Division of AIDS, Office of Clinical Site Oversite (OCSO), Asia and the Americas Branch (AAB) within the National Institute of Allergy and Infectious Diseases (NIAID). Duties and Responsibilities: + Implement and coordinate a range of individual...

  • Clinical Advisor

    3 weeks ago

    Rockville, United States GAP Solutions, Inc. (GAPSI) Full time

    Position Objective: Provide services as a Clinical Advisor in support of the overall functions of the Division of AIDS, Office of Clinical Site Oversite (OCSO), Asia and the Americas Branch (AAB) within the National Institute of Allergy and Infectious Diseases (NIAID). Duties and Responsibilities: Implement and coordinate a range of individual...

  • Clinical Advisor

    2 weeks ago

    Rockville, Maryland, United States GAP Solutions, Inc. (GAPSI) Full time

    Position Objective: Provide services as a Clinical Advisor in support of the overall functions of the Division of AIDS, Office of Clinical Site Oversite (OCSO), Asia and the Americas Branch (AAB) within the National Institute of Allergy and Infectious Diseases (NIAID). Duties and Responsibilities: Implement and coordinate a range of individual clinical...

  • Clinical Advisor

    4 weeks ago

    Rockville, United States Columbus Technologies Full time

    Overview: Must be a US Citizen or Green Card Holder W2 with full benefit Some travel may be required Offer contingent on ability to successfully pass a background check and drug screen Columbus Technologies and Services Inc. is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the...

  • Clinical Advisor

    1 week ago

    Rockville, United States GAP Solutions, Inc. Full time

    Position Objective: Provide services as a Clinical Advisor in support of the overall functions of the Division of AIDS (DAIDS), Therapeutics Research Program (TRP) within the National Institute of Allergy and Infectious Diseases (NIAID). Duties and Responsibilities: Lead the creation, implementation and appropriate closeout of an overall operational plan...

  • Clinical Advisor

    6 days ago

    Rockville, United States GAP Solutions, Inc. (GAPSI) Full time

    Position Objective: Provide services as a Clinical Advisor in support of the overall functions of the Division of AIDS (DAIDS), Therapeutics Research Program (TRP) within the National Institute of Allergy and Infectious Diseases (NIAID). Duties and Responsibilities: Lead the creation, implementation and appropriate closeout of an overall operational plan...

  • Clinical Advisor

    4 days ago

    Rockville, United States Axle Full time

    (ID: 2024-5250) **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...

  • Clinical Advisor

    7 days ago

    Rockville, United States Axle Full time

    (ID: 2024-5258) **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...

  • Clinical Advisor

    4 weeks ago

    Rockville, United States RJ IT Solutions Full time

    RJIT Solutions is an information technology and bioscience company that specializes in providing innovative solutions in biomedical research and data science. We serve healthcare organizations by leveraging the expertise of our team in science, software engineering, program/project management. Our commitment to excellence has made us a trusted partner of top...

  • Clinical Advisor

    3 weeks ago

    Rockville, United States RJ IT Solutions Full time

    RJIT Solutions is an information technology and bioscience company that specializes in providing innovative solutions in biomedical research and data science. We serve healthcare organizations by leveraging the expertise of our team in science, software engineering, program/project management. Our commitment to excellence has made us a trusted partner of top...

  • Clinical Advisor

    3 weeks ago

    Rockville, United States RJ IT Solutions Full time

    RJIT Solutions is an information technology and bioscience company that specializes in providing innovative solutions in biomedical research and data science. We serve healthcare organizations by leveraging the expertise of our team in science, software engineering, program/project management. Our commitment to excellence has made us a trusted partner of top...

  • Clinical Advisor

    3 weeks ago

    Rockville, United States GAP Solutions, Inc. Full time

    Provide services as a Clinical Advisor (Clinical Data Management) (Part-Time) in support of the overall functions of the Division of AIDS (DAIDS), Office for Policy in Clinical Research Operations (OPCRO) within the National Institute of Allergy and Infectious Diseases (NIAID). **Duties and Responsibilities**: - Provide data management expertise to federal...

  • Senior Clinical Research Advisor

    3 weeks ago

    Rockville, United States Axle Full time

    Job DescriptionJob Description(ID: 2024-4914)Axle 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 nationally and abroad. With experts in biomedical science, software engineering, and program management,...

  • Senior Clinical Research Advisor

    2 weeks ago

    Rockville, United States Axle Full time

    Job DescriptionJob Description(ID: 2024-4914)Axle 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 nationally and abroad. With experts in biomedical science, software engineering, and program management,...

  • Advisor in Bioinformatics

    2 weeks ago

    Rockville, United States National Institutes of Health Full time

    Job Summary The Advisor in Bioinformatics will provide leadership in the use of innovative methodologies, statistical design, and data science for surveillance research at the NCI and NIH. The incumbent will also provide consultation to Institute leadership in establishing policies involving highly complex, novel statistical support for research with...

  • Chemical Biological Radiological Nuclear Scientific Advisor

    4 weeks ago

    Rockville, Maryland, United States National Institute of Allergy and Infectious Diseases (NIAID) Full time

    Chemical Biological Radiological Nuclear Scientific AdvisorChief, Biodefense Research Countermeasures BranchThe National Institute of Allergy and Infectious Diseases (NIAID), one of the largest institutes in the National Institutes of Health (NIH), and part of the Department of Health and Human Services (HHS), conducts and supports basic and applied research...

  • Mental Health Scientific Diversity Officer

    5 days ago

    Rockville, United States National Institute of Mental Health Full time

    The NIMH Mental Health Scientific Diversity Officer will serve as the senior scientific expert to the NIMH Director and be responsible for providing leadership and direction for all diversity, equity, inclusion and accessibility requirements within NIMH and initiatives as related to the planning, design, and promotion of strategies and programs to support...

  • Mental Health Scientific Diversity Officer

    7 days ago

    Rockville, Maryland, United States National Institute of Mental Health Full time

    The NIMH Mental Health Scientific Diversity Officer will serve as the senior scientific expert to the NIMH Director and be responsible for providing leadership and direction for all diversity, equity, inclusion and accessibility requirements within NIMH and initiatives as related to the planning, design, and promotion of strategies and programs to support...

  • Mental Health Scientific Diversity Officer

    3 weeks ago

    Rockville, United States National Institutes of Mental Health Full time

    The NIMH Mental Health Scientific Diversity Officer will serve as the senior scientific expert to the NIMH Director and be responsible for providing leadership and direction for all diversity, equity, inclusion and accessibility requirements within NIMH and initiatives as related to the planning, design, and promotion of strategies and programs to support...