Clinical Research Coordinator

Axle; Rockville (MD); On-site; USD 140,000 - 155,000; Full time

Benefits offered by this job

Paid Time Off

401K match

Educational Benefits

Employee Referral Bonus

Healthcare FSA

Parking Reimbursement

Dependent Care Assistant Program (DCAP

Transportation Reimbursement Account (

Job summary

Axle, a bioscience and IT company, is seeking a Clinical Research Coordinator to join the NIH/NIAID team in Bethesda, MD. You will provide scientific staffing support for DIR, assist with study design and procedures, and ensure ICH GCP compliance throughout patient enrollment and follow-up.

Strong clinical research background and leadership experience are required, with Spanish language skills preferred. The role offers a market-competitive salary range, benefits including PTO, 401K, and

Qualifications

• Minimum of at least 5 years of clinical research experience.
• 2 years of team lead experience.
• Bilingual Spanish speaker preferred.
• MS Office proficiency.
• Field of Study: Health and Medical Administrative Services.

Responsibilities

• Assist, coordinate and implement all components of clinical research protocols, including pre and post research activities.
• Meet with lab members to present updates - Daily
• Assist study team members in developing an understanding of study design and rationale and support team members in implementation and study procedures.
• 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.

Skills

Clinical research experience

Team leadership

Tools

MS Office

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 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:

• 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

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: [e-mail]

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.

Salary Range

$140,000 - $155,000 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.