Clinical Research Coordinator

Axle • Rockville, MD

11d • 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), National Institutes of Health (NIH), in Bethesda, Maryland. The role coordinates and implements clinical research protocols and supports research teams, clinical staff, study participants, and associated workflows. Responsibilities include ensuring compliance with ICH Good Clinical Practice (GCP), supporting participant enrollment and follow-up, collecting and managing research data, tracking adverse events, and improving the quality and efficiency of study conduct. The position also supports training, recruitment and retention planning, research project development, and clinical research tools and processes.

Requirements

• At least 5 years of clinical research experience.
• At least 2 years of team lead experience.
• Skills in Microsoft Office.

Nice To Haves

• Bilingual Spanish speaker preferred.

Responsibilities

• Assist, coordinate, and implement clinical research protocols, including pre- and post-research activities inside and outside clinical settings.
• Help study team members understand study design and rationale and support the implementation of study procedures.
• Anticipate and mitigate risks and unplanned circumstances affecting patient 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, patient 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 the development of forms and questionnaires and collect data from patient charts, medical records, interviews, questionnaires, and diagnostic tests.
• Provide technical experience needed to operate clinic administrative functions.
• Monitor subject progress and report adverse events.
• Build relationships with non-research departments to support clinical department workflows.
• Support the assembly, development, and review of new research projects.
• Design recruitment and retention plans for studies.
• Support the 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 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 improve study conduct quality.
• Run validation monthly.
• 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: Healthcare (FSA), Parking Reimbursement Account (PRK), Dependent Care Assistance Program (DCAP), and Transportation Reimbursement Account (TRN)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed