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). Overview Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Clinical Protocol Manager to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID),Division of Allergy, Immunology and Transplantation, (DAIT).
Responsibilities
Provide support to clinical investigators and their staff in the development of clinical trial and observational study protocols and informed consent forms.
Provide support to clinical investigators and their staff in the development and implementation of study SOPs.
Oversee clinical trials and large observational studies, e.g., track and report on study milestones, oversee site monitoring activities, and review site monitoring reports.
Train and educate clinical site staff about protocol procedures, informed consent processes, regulatory aspects of research and GCP compliance.
Work with CRAs or other extramural workers to monitor sites for regulatory compliance, e.g. site and staff licensing.
Work with CRAs or other extramural workers to monitor sites for protocol compliance, e.g., review site reports.
Provide guidance to site staff throughout the course of a clinical or observational study.
Develop and maintain internal documents for clinical trials not supported by Clinical Research Organizations.
Overall, during study development and throughout the duration of a clinical study, provide guidance and recommendations to investigators and their staff, as well as to other DAIT/NIAID staff involved in the study.
Experience Required / Requirements
RN, NP, PA or MD degrees (practicing license not necessary)
Minimum of three (3) years recent experience in managing, conducting or monitoring clinical trials.
Current GCP training.
Experience in clinical data management.
Familiarity with IRB requirements.
Excellent writing skills
Benefits
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: careers@axleinfo.com 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.