Clinical Protocol Coordinator

Overview

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 Coordinator  to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of Intramural Research (DIR), Laboratory of Allergic Diseases (LAD).  Responsibilities

• Provide advanced expertise in clinical trial coordination and implementation, data and protocol management. Oversee the implementation, tracking, data abstraction and collection, data reporting, and coordination of a variety of clinical trials in affiliation with the NIAID/DIR program.
• Interview, screen and recruit patients for entry onto protocols.
• Ensure that families of participants are properly consented and understand implications of genetic research. Screen patients, obtain medical history, and acquire outside medical records and pathology specimens, while addressing complex ethical and legal implications.

• Perform, and/or coordinate the collection, processing and handling of laboratory samples including appropriate storage and shipping.
• Coordinate the procurement of samples from referring physicians worldwide to further the laboratory's research.
• Monitor response to therapy and adjusts plan of care per protocol specifications, standards of practice, and other guidelines.
• Use sound judgment and clinical expertise to adjust patients' plans of care in the absence of established guidelines.
• Document informed consents in CRIS and CRIMSON patient medical information systems.
• Manage protocols relating to human subjects research and the collection and processing of human samples procured under the auspices of NIH IRB-approved clinical research protocols.
• Work to maintain NIH IRB protocol and office files, databases, and records. Provide administrative and technical guidance to investigators and institute staff on NIH IRB functions.
• Assist investigators and staff and ensure that all NIH IRB policies and procedures are disseminated to the Federal Task Leader and other appropriate program staff via written and electronic communication.
• Assist the clinic staff with regard to Investigator Brochure information, protocol implementation, general and specific data collection and research practices.
• Direct health care members in the execution of trials and resolution of logistical constraints and assures all aspects of Good Clinical Practice (GCP) and federal regulatory requirements are met or exceeded.
• Assist and explain to families on basic concepts of the human immune system and hereditary disease as it relates to their illness.
• Establish rapport and works with families under stress, provide emotional support and refers to appropriate resources.
• Process and guide research protocols through the review cycle of submission, initial review, continuing review, amendments, and reporting. Obtain translations of protocol consents into various languages and updates translated consents as needed. Arrange for translators in advance of protocol visits.
• Assist in preparing and analyzing clinical data for publication in biomedical journals.
• Serve as a primary contact point for the Laboratory for protocol procedures and regulations.
• Provide administrative and technical guidance for new investigators.
• Conduct educational presentations to nursing units, clinics and other departments collaborating on NIAID clinical trials.
• Ensure compliance with training for protection of human subjects, conflict of interest guidelines, and patient confidentiality. Ensure accurate and timely entry of data to bio-specimen databases.
• Maintain integrity of databases by conducting periodic audits and reports to Laboratory chief.
• Provide advice and expertise to technicians on maintaining Clinical Laboratory Improvement
• Amendment (CLIA) certification for the Laboratory where appropriate and participates in CLIA
• inspections.
• Serve as a primary contact point for the Laboratory in regard to protocol procedures, regulations and requirements. Serves as the liaison between various individuals and offices involved in the oversight of human subjects research at the NIH including, but not limited to, the NIH IRB, the NIAID Clinical Director, the Office of Human Subjects Research, the NIH Office of Clinical Research, NIH Clinical Center Office of Protocol Services, Deputy Ethics Coordinators, NIAID’s Technology Transfer and Intellectual Property Office (TTIPO), and investigators.
• Serve as the liaison between Laboratory and other teams in NIAID, clinical nursing staff, NIH Clinical Center Staff, other institutes and centers of the NIH, extramural collaborators, referring physicians, patients and their families.
• Participate in the development and maintenance of hard copy and electronic systems to prepare, monitor and track protocols and submissions. Participate in the development and maintenance of systems used to manage databases and to monitor compliance with applicable regulations. Maintain files and records on all protocols for the required periods of time.
• Creatively solve problems related to obtaining viable patient samples from international locations and from patients with limited resources.
• Collaborate with many of the following professionals and/or organizations: pharmacy, laboratories, pharmaceutical agencies/sponsors and monitors, Contract Research Organizations, the Food and Drug Administration, and the Institutional Review boards and IND holders.
• Direct and 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.
• Report data to appropriate regulatory and monitoring agencies. Anticipate and create database/case reports to meet protocol needs. Translate data collection needs into clinic wide standards and tools, collaborating with resources beyond the intramural setting to maintain data collection tools.
• Perform activities to facilitate the ease of reporting, avoidance of repetition of data entry procedures, and generation of reports appropriate to various agencies.
• Stay current with NIH IRB requirements. Prepare reports and respond to outside inquiries and audits from IRB oversight and regulatory offices including, but not limited to, the NIH Intramural Research Program’s Human Research Protections Program, the NIH Office of Human Subjects Research Protections, and the HHS Office of Human Research Protections.
• Design and maintain a selection of material appropriate to send to health care referral sources seeking eligibility information or for other appropriate objectives.
• Analyze data, note trends and implications of same, publishes and presents finding locally, nationally and internationally representing NIAID and DIR.
• Use advanced communication skills to problem solve complex or unpredictable situations and to improve processes and services to patients and colleagues.
• Write expert documents relevant to research, clinical care and related subjects including published works and executive reports.
• Act as a mentor to students and nurse specialists/practitioners new to the NIAID/ NIH Clinical Center environment. Provide information and educating to others in the field of expertise including lecturing at colleges and continuing education programs.
• Participate in clinical practice and research support peer review and develops multidisciplinary performance improvement programs and projects. Maintain an overview of the clinical program in order to collaborate and contributes to planning and resource allocation.
• Collaborate with peers and other multidisciplinary team members to analyze and evaluate current systems of health care delivery and to identify and implement new practice patterns as appropriate.

Experience Required / Requirements

• BSN or MSN degree, and a valid Nursing license is required.
• Minimum two (2) years of related work experience is required.
• Experience in pediatric nursing is required.
• Effective communication skills working in a collaborative team atmosphere.
• Ability to maintain strict compliance with IRB, NIH and Federal Regulations governing human subjects research.

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.