Clinical Protocol Coordinator


Axle Informatics 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 around the globe. 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 highly ambitious, adaptable, structured, and detail-oriented Clinical Protocol Coordinator to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Laboratory of Immunoregulation (LIR), Division of Intramural Research (DIR).


Manage clinical protocols by assisting in training the study team and other staff members, oversees compliance to protocol, develop and adhere to relevant SOPs; manage quality control, completion and submission of study related documents; help in preparation, submission and maintenance of IRB, FDA, and/or other regulatory documents and research correspondence.

Assist in development of informed consent and screening materials. Schedule and oversee study visits to NIH as needed.

Interview, screen, recruit and enroll patients in IRB approved clinical trial protocols.

Obtain informed consent/assent and addresses complex ethical and legal implications of same.

Perform quality assurance and quality control activities as they relate to protocol adherence, protocol monitoring, data collection, data abstraction, and data analysis and assures standard operating procedures reflect the highest standards of data integrity and patient safety.

Use advanced communication skills to problem solve complex or unpredictable situations and to improve processes and services to patients and colleagues.

Maintain study subject databases; oversee data collection and management including the collection of source documents, using and developing CRFs, and ensuring that they are complete and accurate.

Contribute to developing educational materials and educate the community and other research professionals regarding studies and related research issues. Assist with training staff members.

Receive patient care phone calls, furnish the requested information, or refer callers to the appropriate staff members.

Assist in medical documentation.

Recruit volunteers for all protocols and collect and report census for all open protocols.

Abstract medical information from medical history, medications and preexisting conditions for new participants.

Build and maintain excellent communication with Principal Investigators and others needed to conduct quality research to foster an excellent reputation of site research.

Ensure efficient monitoring of all trials by ensuring that the data is clean and entered accurately into the sponsor EDC in timely fashion.

Assist in data analysis and manuscript preparation.

Manage patient safety and report adverse/serious adverse events, protocol violations/deviations in a timely and accurate manner

Experience Required / Requirements

Bachelor’s degree in nursing.

Licensed as a nurse in the state of Maryland.

Minimum of 9 years of experience in clinical research setting with protocols and clinical trials is required.

Knowledge of federal regulatory requirements pertaining to clinical research.

Knowledge of Good Clinical Practice (GCP).

Knowledge pertaining to privacy of the patient, privileged information and secure handling of the patient’s medical records.

NIH clinical trials experience preferred

This position and duties may be conducted remotely upon approval.


100% Medical, Dental & Vision premium coverage for Employees

Paid Time Off (Including Holidays)

Employee Referral Bonus

401K Match

Tuition reimbursement and professional development opportunities

Flexible Spending Accounts:

Healthcare (FSA)

Parking Reimbursement Account (PRK)

Dependent Care Assistant Program (DCAP)

Transportation Reimbursement Account (TRN)

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 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:

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

Job Type
Full Time
71 days ago

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