(ID: 2026-3898)

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 of Allergy and Infectious Diseases (NIAID) located in Bethesda, MD.

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 Information:

Provide scientific staffing support for the Division of Intramural Research (DIR), National Institute of Allergy and Infectious Diseases (NIAID)

Additional Qualifications:

Certifications & Licenses

• Bilingual Spanish speaker preferred

Field of Study

• Health and Medical Administrative Services

Software

• MS Office

Skills

• Minimum of at least 5 years of clinical research experience and 2 years of team lead experience

Deliverables:

• Run Validation - Monthly

• Meet with lab members to present updates - Daily

Statement of Work Details:

• Assist, coordinate and implement all components of clinical research protocols, including pre and post research activities, internal and external to the clinical setting. - 1
• Assist study team members in developing an understanding of study design and rationale and support team members in implementation and study procedures. - 2
• Anticipate and mitigate risks and unplanned circumstances impacting patient qualification and data collection. - 3

• Supports clinical staff develop, implement and maintain clinical research data files and materials.

• Ensure ICH GCP compliance with execution of protocols, patient enrollment and follow up, adverse event management and reporting and study activities.

• Request and initiate the purchase of materials, supplies and equipment.

• Demonstrate skills in navigating and troubleshooting a wide variety of e-clinical technologies.

• Collects research data and prepares information for inputs and analysis.

• Supports the development of forms and questionnaires.

• Supports the collection of data from patient charts, medical records, interviews, questionnaires, and diagnostic tests.

• Provide technical experience needed to operate the administrative functions within the clinic.

• Monitors subject's progress and reports adverse events.

• Establish relationships with non-research departments as needed for essential workflow within the clinical departments.

• Supports assembly, development and review of new research projects.

• Design recruitment and retention plans to support the study.

• Supports the creation and management of clinical websites and web-based tools.

• Work to implement the policies and procedures of the program with the clinical research team.

• Organizes and performs clinical research, utilizing internet and other available clinical resources.

• Supply study progress metrics for weekly reporting.

• Provides assistance to staff in the collection, development and quality control of essential clinical research efforts.

• Ensure ICH GCP compliance with execution of protocols, patient enrollment and follow up, adverse event tracking and study activities.

• Supports clinical staff develop, implement and maintain clinical research data files and materials.

• Design and implement quality assurance and quality-control procedures within the day-to-day research activities.

• Develops and facilitates training to new research coordinators and mentors' researchers in Good Clinical Practices.

• Monitor efficiency of procedures and contribute to the development of SOPs and internal processes to enhance the quality of study conduct.

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.

Accessibility: If you need an accommodation as part of the employment process please contact: [email protected]

This role has a market-competitive salary with an anticipated base compensation range listed below. Actual salaries will vary depending on a candidate’s experience, qualifications, skills, and location.

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