Clinical Research Coordinator

Axle•Rockville, MD

11d•$140,000 - $155,000•Onsite

About The Position

Axle is seeking a Clinical Research Coordinator to provide scientific staffing support for the Division of Intramural Research at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), in Bethesda, Maryland. The role coordinates and implements clinical research protocols and supports clinical teams with study conduct, participant enrollment and follow-up, data collection, compliance, quality assurance, and training. The coordinator supports study planning and execution, helps staff understand study design and procedures, monitors participant progress and adverse events, and works with clinical and non-research departments to support essential workflows. The role also contributes to recruitment and retention plans, research materials and data files, study reporting, clinical web tools, standard operating procedures, and process improvements. The position requires at least five years of clinical research experience and two years of team lead experience.

Requirements

At least 5 years of clinical research experience.
At least 2 years of team lead experience.
Field of study: Health and Medical Administrative Services.
Experience with MS Office.

Nice To Haves

Bilingual Spanish speaker preferred.

Responsibilities

Assist, coordinate, and implement all components of clinical research protocols, including pre- and post-research activities within and outside the clinical setting.
Help study team members understand study design and rationale, and support implementation of study procedures.
Anticipate and mitigate risks and unplanned circumstances that may affect participant qualification and data collection.
Support clinical staff in developing, implementing, and maintaining clinical research data files and materials.
Ensure ICH GCP compliance in protocol execution, participant enrollment and follow-up, adverse-event management and reporting, and other study activities.
Request and initiate purchases of materials, supplies, and equipment.
Navigate and troubleshoot e-clinical technologies.
Collect research data and prepare information for input and analysis.
Support development of forms and questionnaires.
Support data collection from patient charts, medical records, interviews, questionnaires, and diagnostic tests.
Provide technical experience needed to operate clinic administrative functions.
Monitor participants’ progress and report adverse events.
Establish relationships with non-research departments to support essential clinical workflows.
Support assembly, development, and review of new research projects.
Design recruitment and retention plans to support studies.
Support creation and management of clinical websites and web-based tools.
Implement program policies and procedures with the clinical research team.
Organize and conduct clinical research using internet and other available clinical resources.
Supply study progress metrics for weekly reporting.
Assist staff with collection, development, and quality control of essential clinical research efforts.
Design and implement quality-assurance and quality-control procedures for day-to-day research activities.
Develop and facilitate training for new research coordinators and mentor researchers in Good Clinical Practices.
Monitor procedural efficiency and contribute to SOPs and internal processes that enhance study quality.
Run validation monthly and meet with lab members daily to present updates.

Benefits

100% medical, dental, and vision coverage for employees.
Paid time off and paid holidays.
401(k) match up to 5%.
Educational benefits for career growth.
Employee referral bonus.
Flexible spending accounts, including healthcare FSA, parking reimbursement account, dependent care assistance program, and transportation reimbursement account.

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