Senior Research Associate

Axle; Rockville (MD); Hybrid; USD 145,000 - 153,000; Full time

Benefits offered by this job

100% Medical, Dental & Vision Coverage

Paid Time Off and Holidays

401K match up to 5%

Educational Benefits for Career Growth

Employee Referral Bonus

Flexible Spending Accounts: Healthcare

Parking Reimbursement Account

Dependent Care Assistant Program

Transportation Reimbursement Account

Job summary

Axle, a bioscience and IT company, is seeking a Senior Research Associate (Clinical Protocol Coordinator) to support the NIH Clinical Center's Department of Perioperative Medicine in Bethesda, MD. This full-time role involves protocol development, regulatory submissions, data management, and staff training.

The position requires a Master’s degree, CITI certification, and experience with clinical trials. It is based at NIH Bethesda with telework eligibility and a Monday–Friday schedule.

Qualifications

• Master's degree in General Medical and Health Services or related field.
• CITI certification.
• Experience with regulatory submission processes and IRB documentation.

Responsibilities

• Assist researchers with protocol development and review of trial documents.
• Maintain trial-related documentation and study databases.
• Collect and submit regulatory documents to IRB and regulatory bodies.
• Support participant recruitment and scheduling; train staff on protocol submissions.
• Train investigators and staff on protocol submission processes.

Skills

Liaising with regulatory authorities

Training clinical trial site staff

Coordinating project meetings

Previous clinical trial work

Education

Master's degree

Tools

Electronic Data Capture System

Job description

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 Senior Research Associate to join our vibrant team at the National Institutes of Health (NIH) supporting the Clinical Center (CC) located in Bethesda, MD.

(ID: 2026-3925)

Benefits We Offer:

• 100% Medical, Dental & Vision Coverage for Employees
• Paid Time Off and Paid Holidays
• 401K match up to 5%
• Educational Benefits for Career Growth
• Employee Referral Bonus
• Flexible Spending Accounts:
  • Healthcare (FSA)
  • Parking Reimbursement Account (PRK)
  • Dependent Care Assistant Program (DCAP)
  • Transportation Reimbursement Account (TRN)

Position Overview

The Senior Research Associate (Clinical Protocol Coordinator) will support the clinical and basic research programs of the Department of Perioperative Medicine in the NIH Clinical Center. Responsibilities include assisting researchers with protocol development and the assembly and review of clinical trial documents, maintaining trial-related documentation and study databases, collecting and submitting regulatory documents to the IRB and other regulatory bodies, supporting participant recruitment and scheduling, and training staff and investigators on protocol submission processes. A Master's degree is required, with General Medical and Health Services listed as the field of study. This position is based at the NIH campus in Bethesda, MD (Monday through Friday, 40 hours per week) and is telework eligible.

Additional Qualifications

Certifications & Licenses

• Master's degree
• CITI certification

Field of Study

• General Medical and Health Services

Software

• Electronic Data Capture System

Skills

• Liaising with regulatory authorities
• Training clinical trial site staff
• Coordinating project meetings
• Previous clinical trial work

Deliverables

• Meet with lab members to present updates — Bi-Weekly
• Present clinical updates to include patient enrollment, progress in trial, recruitment, data collection, and regulatory and clinical data — Bi-Weekly
• Generate weekly reports outlining progress and status of ongoing activity — Weekly
• Enter and oversee data storage in database — Ad-Hoc
• Work with investigators to facilitate patients' care during clinical visits — Ad-Hoc
• Meet and update investigators on the trial status and on protocol and regulatory updates — Ad-Hoc
• Compile data and produce presentations for scientific or regulatory meetings — Ad-Hoc

Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individuals 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.

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 on 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.

Salary Range

$145,000 - $153,000 USD

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.

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.