Clinical Research Coordinator
Axle, Bethesda, MD, United States
Overview
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, 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).
Axle is seeking a
Clinical Research Coordinator
to join our vibrant team at the National Institutes of Health (NIH) supporting the
National Institute on Aging (NIA)
located in Bethesda, MD.
Benefits
Paid Time Off and Paid Holidays
401K match up to 5%
Educational Benefits for Career Growth
Employee Referral Bonus
Flexible Spending Accounts
Flexible Spending Accounts include: Healthcare (FSA), Parking Reimbursement Account (PRK), Dependent Care Assistant Program (DCAP), Transportation Reimbursement Account (TRN).
Position Information
Provide support services to satisfy the overall operational objectives of the NIH/NIA. The primary objective is to provide services and deliverables through performance of support services. Work products and documents include lists of applications approved for award that are classified as Clinical Trials (CTs) and related risk assessments, DSMB-related materials, compliance tracking, adverse event coding, and communications with investigators and program staff.
Statement of Work Details (Selected Responsibilities)
Provide administrative and management support of experimental studies with human subjects and the appropriate conduct of behavioral interventions for applications identified by NIA staff as being considered for award.
Review and identify suitable applications for award to be classified as Clinical Trial (CT), ensuring all approved applications are correctly specified.
Report findings of CT applications, by developing summary statements to identify Human Subjects Concerns and request necessary corrections from the applicant via email.
Advise applicants that Authorized Organizational Representative (AOR) concurrence is required on responses, in collaboration with the Clinical Trial Coordinator (CTC).
Identify CT applications that meet NIA criteria requiring a Data and Safety Monitoring Board (DSMB) and track related documentation.
Other duties include supporting DSMB processes, data management plans, enrollment tracking, regulatory compliance, and communications with PIs, AORs, and PO offices as part of NIH/NIA policies.
Qualifications
Degree in a related discipline
Field of Study: Health and Medical Administrative Services; General Medical and Health Services
Software: MS Office Suite
Skills: Strong oral and written communications
Disclaimer
The above description is meant to illustrate the general nature of work and level of effort. This is not a complete list of all skills, responsibilities, duties, and/or assignments required. Employees may be required to perform duties outside of their position as needed. The diversity of Axle’s employees is a tremendous asset. We are committed to equal opportunity in all aspects of employment and do not tolerate discrimination or harassment based on protected characteristics. Accessibility accommodations are available upon request at careers@axleinfo.com.
This role has a market-competitive salary with an anticipated base compensation range. Salary Range: $135,000 USD - $145,000 USD.
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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, 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).
Axle is seeking a
Clinical Research Coordinator
to join our vibrant team at the National Institutes of Health (NIH) supporting the
National Institute on Aging (NIA)
located in Bethesda, MD.
Benefits
Paid Time Off and Paid Holidays
401K match up to 5%
Educational Benefits for Career Growth
Employee Referral Bonus
Flexible Spending Accounts
Flexible Spending Accounts include: Healthcare (FSA), Parking Reimbursement Account (PRK), Dependent Care Assistant Program (DCAP), Transportation Reimbursement Account (TRN).
Position Information
Provide support services to satisfy the overall operational objectives of the NIH/NIA. The primary objective is to provide services and deliverables through performance of support services. Work products and documents include lists of applications approved for award that are classified as Clinical Trials (CTs) and related risk assessments, DSMB-related materials, compliance tracking, adverse event coding, and communications with investigators and program staff.
Statement of Work Details (Selected Responsibilities)
Provide administrative and management support of experimental studies with human subjects and the appropriate conduct of behavioral interventions for applications identified by NIA staff as being considered for award.
Review and identify suitable applications for award to be classified as Clinical Trial (CT), ensuring all approved applications are correctly specified.
Report findings of CT applications, by developing summary statements to identify Human Subjects Concerns and request necessary corrections from the applicant via email.
Advise applicants that Authorized Organizational Representative (AOR) concurrence is required on responses, in collaboration with the Clinical Trial Coordinator (CTC).
Identify CT applications that meet NIA criteria requiring a Data and Safety Monitoring Board (DSMB) and track related documentation.
Other duties include supporting DSMB processes, data management plans, enrollment tracking, regulatory compliance, and communications with PIs, AORs, and PO offices as part of NIH/NIA policies.
Qualifications
Degree in a related discipline
Field of Study: Health and Medical Administrative Services; General Medical and Health Services
Software: MS Office Suite
Skills: Strong oral and written communications
Disclaimer
The above description is meant to illustrate the general nature of work and level of effort. This is not a complete list of all skills, responsibilities, duties, and/or assignments required. Employees may be required to perform duties outside of their position as needed. The diversity of Axle’s employees is a tremendous asset. We are committed to equal opportunity in all aspects of employment and do not tolerate discrimination or harassment based on protected characteristics. Accessibility accommodations are available upon request at careers@axleinfo.com.
This role has a market-competitive salary with an anticipated base compensation range. Salary Range: $135,000 USD - $145,000 USD.
#J-18808-Ljbffr