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 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 highly ambitious, adaptable, structured, and detail-oriented Clinical Protocol Coordinator to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute of Neurological Disorders and Stroke (NINDS) located in Bethesda, MD.
Overall Position Summary and Objectives Under this task order, the contractor will independently provide support services to satisfy the overall operational objectives of the Division of Intramural Research, Stroke Branch, Stroke Diagnostics and Therapeutics Section at the National Institute of Neurological Disorders and Stroke. The primary objective is to provide services and deliverables through performance of support services.
- Work products and documents related to planning and execution of the most appropriate approaches to attain the laboratory’s research goals. - Daily
- Work products and documents related to measuring project performance to identify areas for improvement. - Daily
- Work products and documents on the evaluation of new types of research approaches and recommended changes to processes/protocols, based on review and knowledge of the research priorities, available staff and facilities. - Daily
- Work products and documents related to data collection, patient follow up, data quality and database maintenance. - Daily
- Work products and documents related to Stroke Branch lab activities, meetings, collaborations and publication record. - Daily
- Meet with lab members to present updates - Ad-Hoc
- Assist with the planning and execution of the most appropriate approaches to attain the laboratory’s research goals.
- Develop or improve systems of data collection, verification and management.
- Evaluate and recommend new types of research approaches and recommend changes to processes/protocols, based on review and knowledge of the research priorities.
- Measure project performance to identify areas for improvement.
- Support the revision and development of human subject’s protocols as needed and assist with the coordination of activities and approvals.
- Perform data collection validation and analysis, including regular internal audits of collected data at the research sites.
- Recommend and assist with the implementation of improvements to work-flow and operational procedures to increase efficiency, productivity and make overallimprovements for research activities.
- Coordinate with PI and Senior Protocol Advisor to help coordinate research staff at multiple sits where research is conducted to assist with the planning, implementation and monitoring of the clinical research protocols. Provide weekly to monthly progress reportson research projects.
- Initiate and track research agreements and material transfer agreements (MTA) with all projects and researchers to define rights of the provider and recipient, in respect to data and its derivatives.
- Work with staff on the training of personnel, research assistants, post-doctoral fellows, students, visiting scientists and others in specialized technologies.
- Collaborate with staff on the preparation of internal research proposals, abstract submissions, poster presentations and manuscript drafts.
- Assists researchers with protocol development, assembly and review of clinical trial documents.
- Assist researchers develop, prepare internal research proposals, abstract submissions, poster presentations and manuscript drafts. 1
- Assist researchers develop protocol documentation including schemas, patient calendars and teaching aids. 2
- Assist researchers develop clinical research informed consent and other ethics and regulatory related documentation. 3
- Assist researchers develop standard operating procedures (SOPs) for the clinical study.
- Assist researchers prepare study reports and status updates, including amendments, audits and other administrative documentation.
- Assists researchers develop and maintain trial related documents and operational procedures.
- Assist researchers collect, organize and maintain all study documentation to include investigator qualifications, trial logs, and safety reports.
- Assist researchers maintain accurate records of all protocols and study applications, safety reports, annual reports and correspondence. 4
- Assist researchers write and edit study protocols, and prepare amendments, reviews, reports, and other necessary forms. 5
- Assist researchers prepare and submit study safety reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
- Assist researchers track and review adverse event files and report events in accordance with Institutional Review Board (IRB) processes and policies.
- Maintains study databases and conducts basic analysis.
- Maintain data files within multiple software systems, including computerized procurement reports and communication programs.
- Perform entry and cleanup of study of the questionnaire data in various databases, and conduct queries to answer researcher questions.
- Assist researchers track study requests and protocol approvals, maintaining a record of all submissions and status of approvals.
- Assist researchers prepare, review and submit clinical data to monitoring agencies.
- Assists researchers collect, distribute and file regulatory documents.
- Assist researchers prepare and communicate with IRB and NIH Clinical Center for protocol approval.
- Assist researchers prepare submissions to regulatory bodies in support of clinical trials.
- Provides technical support to researchers and the clinic.
- Assist staff on protocol coordination, including matching and locating control subjects, completing registration phone calls, reviewing study questionnaires and resolving queries with patients.
- Assist researchers coordinate recruitment, scheduling, travel and admission of research study participants with clinical staff.
- Assist researchers screen study participants and document results of screenings.
- Liaison between study participants, participants’ relatives and staff members and communicate participants’ questions, complaints, problems and concerns to appropriate staff members.
1, 2, 3, 4, 5 represents priority rankings, where 1 is highest priority and 5 is lowest priority of those ranked
Certifications & Licenses
- Minimum of one (1) years of experience in clinicalresearch coordination or related field.
- Familiarity with IRB requirements.
Field of Study
- General Medical and Health Services
- Clinical Trial Management System (CTMS)
- Microsoft Office Products
- Electronic Data Capture System
- Experience in clinical data management databases operations and analysis
- Liaising with regulatory authorities
- Previous clinical trial work
- Regulatory compliance
- Protocol development
- Clinical Research
- Clinical Trials
- Data Monitoring
- 100% Medical Dental & Vision Coverage for Employees
- Educational Benefits for Career Growth
- Paid Time Off (Including Holidays)
- Employee Referral Bonus
- Profit Sharing
- 401K Matching
- 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 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: firstname.lastname@example.org
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.