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    Clinical Advisor - Rockville, United States - Axle Informatics

    Axle Informatics
    Axle Informatics Rockville, United States

    3 weeks ago

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    Description
    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


    join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS).

    Responsibilities
    Implement and coordinate a range of individual clinical site-management activities.
    Advise PIs on clinical site start-up and relevant operational and regulatory issues including resource allocation, and administrative issues.

    Provide leadership for planning, organizing, and conducting site visits or reverse site visits as appropriate to clinical trials units/clinical research sites to effectively fulfill site management responsibilities.

    Assess the level of clinical trials research competency of clinical research site staff and the extent of research knowledge and technology available to achieve the desired quantity and quality of research to be conducted at the clinical research sites.

    Evaluate clinical trials units/clinical research sites' organizational structures and modes of operations in relationship to the achievement of the Division's goals and objectives in the areas of administration, clinical site management, and recruitment of patients.

    Provide oversight and technical direction for evaluation of site performance.

    Identify problems or issues that transcend individual units or trends that indicate the need for procedural clarification or policy development and recommends follow-up actions or policy directives to OCSO Director or Branch Chief.

    Conduct trainings at sites and Network meetings on relevant policies/regulations.
    Attend local Network meetings, conference calls, ad hoc meetings and working groups.
    1) tracking and summarizing grantee compliance with training requirements, grantee progress in meeting the grant aims by reviewing progress reports, and adherence to applicable regulations; and 2) reviewing and providing input on training materials, policies and procedures.
    Participate in the creation and review of site development and site closure-related documents and checklists.
    Interface with networks, investigators, Operations Centers, to share information and collaborate on research and site-related issues.
    Prepare oral and written presentations for internal and external programmatic and scientific meetings

    Experience Required / Requirements
    Minimum of a BS degree in a science or health related discipline.
    Minimum of five (5) years of progressive experience in managing clinical trials/clinical research sites and/or monitoring clinical trials.
    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)

    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:


    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.

    Do you have the legal authorization to work on a full-time, indefinite basis in the country where this role is located?


    • Can you perform the essential functions of this job without reasonable accommodation?
    • Are you willing and able to work at the specified job location, or are you open to relocation if required?
    • Does accepting employment with Axle or performing the duties required for this role conflict with any non compete, non solicitation, or other contractual agreements you may have?
    • Do you meet the eligibility requirements for obtaining a US Government Security Clearance?
    • For government reporting purposes, we ask candidates to respond to the below self identification survey.
    Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

    As set forth in Axle's Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

    If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.

    As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA.


    Classification of protected categoriesis as follows:
    A "disabled veteran" is one of the following: a veteran of the U.S.

    military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

    A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S.

    military, ground, naval, or air service.
    An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S.

    military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

    An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S.

    military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

    Voluntary Self-Identification of Disability

    Form CC-305
    Page 1 of 1
    OMB Control Number
    Expires 04/30/2026
    Voluntary Self-Identification

    For government reporting purposes, we ask candidates to respond to the below self-identification survey.
    Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

    As set forth in Axle's Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

    Gender

    Please select

    Gender

    Are you Hispanic/Latino?

    Please select

    Are you Hispanic/Latino?

    Race & Ethnicity Definitions

    If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.

    As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA.


    Classification of protected categoriesis as follows:
    A "disabled veteran" is one of the following: a veteran of the U.S.

    military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

    A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S.

    military, ground, naval, or air service.
    An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S.

    military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

    An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S.

    military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

    Veteran Status

    Please select

    Veteran Status

    Voluntary Self-Identification of Disability

    Form CC-305

    Page 1 of 1

    OMB Control Number

    Expires 04/30/2026
    Why are you being asked to complete this form?

    We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.
    Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at .
    How do you know if you have a disability?


    A disability is a condition that substantially limits one or more of your "major life activities." If you have or have ever had such a condition, you are a person with a disability.


    Disabilities include, but are not limited to:
    Alcohol or other substance use disorder (not currently using drugs illegally)
    Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
    Blind or low vision
    Cancer (past or present)
    Cardiovascular or heart disease
    Celiac disease
    Cerebral palsy
    Deaf or serious difficulty hearing
    Diabetes
    Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
    Epilepsy or other seizure disorder
    Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
    Intellectual or developmental disability
    Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
    Missing limbs or partially missing limbs
    Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
    Nervous system condition, for example, migraine headaches, Parkinson's disease, multiple sclerosis (MS)
    Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
    Partial or complete paralysis (any cause)
    Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
    Short stature (dwarfism)
    Traumatic brain injury
    Disability Status

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    Disability Status


    PUBLIC BURDEN STATEMENT:

    According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number.

    This survey should take about 5 minutes to complete.

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