Senior Clinical Protocol Coordinator

Axle•Bethesda, MD

About The Position

Axle 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 Senior Clinical Protocol Coordinator to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute of Dental and Craniofacial Research (NIDCR) 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 National Institute of Dental and Craniofacial Research (NIDCR). The primary objective is to provide services and deliverables through performance of clinical research within the NIDCR, Office of the Clinical Director (OCD). Work Details: Educate research staff regarding relevant aspects of regulatory process including requirements of protocol development, conduct of research trials, regulatory change, IRB and FDA submission requirements, radiation safety requirements, ethics clearances, and technology transfer. Prepare and submit documentation for regulatory bodies in support of clinical trials. Communicate with IRB and NIH Clinical Center for protocol approval. Coordinate with IRB administrator to collect, review and maintain all IRB records. Manage, track and report regulatory activities for all assigned protocols, from conception and development, through the protocol lifecycle, to study closure. Assists researchers with protocol development, assembly and review of clinical trial documents. 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 write and edit study protocols, and prepare amendments, reviews, reports, and other necessary forms. Maintains study databases and conducts basic analysis. 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 IRB administrator collect, review and maintain all IRB records. Assist researchers review and submit protocol actions for clearance within the NIH Protocol Tracking and Management System. Organize quality assurance activities with pertinent regulatory bodies such as FDA, NIH, pharmaceuticals and others. 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. Liaison between study participants, participants’ relatives and staff members and communicate participants’ questions, complaints, problems and concerns to appropriate staff members. Develops and assembles clinical trial documents. Develop clinical research informed consent and other ethics and regulatory related documentation. Develops and maintains trial related documents and operational procedures. Prepare and support submission of study safety reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports. Track and review adverse event files and prepare reports in accordance with Institutional Review Board (IRB) processes and policies. Collects and distributes regulatory documents. Prepare researcher communication with IRB and NIH Clinical Center for protocol approval. Prepare submission documentation for regulatory bodies in support of clinical trials. Manage, track and coordinate regulatory activities for all assigned protocols, from conception and development, through the protocol lifecycle, to study closure. Develops, assembles and reviews clinical trial documents. Develop new and review completed IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports. Collects, distributes and files regulatory documents. Coordinate with IRB administrator to collect, review and maintain all IRB records. Conduct quality assurance activities in preparation for regulatory audits by FDA, NIH, pharmaceuticals and others. Prepare and submit documentation for regulatory bodies in support of clinical trials. Reviews and recommends changes to clinical trial documents. Review completed IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports and recommend changes. Reviews and maintains trial related documents and operational procedures. Review records of all protocols and study applications, safety reports, annual reports and correspondence for accuracy and completeness. Review study protocols, and amendments, reviews, reports, and other necessary forms for accuracy and completeness. Review for accuracy and submit study safety reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports. Review for accuracy and completeness adverse event files and prepare reports in accordance with Institutional Review Board (IRB) processes and policies. Collects, distributes and submits regulatory documents. Conduct quality assurance activities in preparation for regulatory audits by FDA, NIH, pharmaceuticals and others. Work with the Institutional Review Board (IRB) to keep abreast of new guidance related to protocol and informed consent submissions for both initial reviews and amendments Develops training plans and trains staff on the proper techniques for protocol submission.

Requirements

Masters
GMP Certified
Pharmacy Pharmaceutical Sciences and Administration
Clinical Trial Management System (CTMS)
REDCap
CAPA
Microsoft Projects/Office
NDA Filing
RedCap
Implementation of clinical trial site action plans
Liaising with regulatory authorities
Coordinating project meetings
Previous clinical trial work
Electronic medical records
Protocol review revision
Phase I or II experience
Patient confidentiality
Preclinical experience
Regulatory compliance
Protocol development
Protocol navigation
Regulatory affairs
Clinical Research
Protocol writing
IRB submissions
Data Monitoring
Data Integrity
Research
SOPs

Responsibilities

Meet with lab members to present updates - Weekly
Work products related to document reviews by the specified deadlines - Weekly
Work products and communication related to meeting preparation and follow up activities, including preparing spreadsheets, letters, rosters, agendas, presentations, managing calendars and meeting minutes/summaries - Weekly
Work products related to tracking and reporting management and oversight activities by specified timelines, as well as follow up activities apprising NIDCR OCD staff of progress and action items - Weekly
Educate research staff regarding relevant aspects of regulatory process including requirements of protocol development, conduct of research trials, regulatory change, IRB and FDA submission requirements, radiation safety requirements, ethics clearances, and technology transfer.
Prepare and submit documentation for regulatory bodies in support of clinical trials.
Communicate with IRB and NIH Clinical Center for protocol approval.
Coordinate with IRB administrator to collect, review and maintain all IRB records.
Manage, track and report regulatory activities for all assigned protocols, from conception and development, through the protocol lifecycle, to study closure.
Assists researchers with protocol development, assembly and review of clinical trial documents.
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 write and edit study protocols, and prepare amendments, reviews, reports, and other necessary forms.
Maintains study databases and conducts basic analysis.
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 IRB administrator collect, review and maintain all IRB records.
Assist researchers review and submit protocol actions for clearance within the NIH Protocol Tracking and Management System.
Organize quality assurance activities with pertinent regulatory bodies such as FDA, NIH, pharmaceuticals and others.
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.
Liaison between study participants, participants’ relatives and staff members and communicate participants’ questions, complaints, problems and concerns to appropriate staff members. Develops and assembles clinical trial documents.
Develop clinical research informed consent and other ethics and regulatory related documentation.
Develops and maintains trial related documents and operational procedures.
Prepare and support submission of study safety reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
Track and review adverse event files and prepare reports in accordance with Institutional Review Board (IRB) processes and policies.
Collects and distributes regulatory documents.
Prepare researcher communication with IRB and NIH Clinical Center for protocol approval.
Prepare submission documentation for regulatory bodies in support of clinical trials.
Manage, track and coordinate regulatory activities for all assigned protocols, from conception and development, through the protocol lifecycle, to study closure.
Develops, assembles and reviews clinical trial documents.
Develop new and review completed IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports. Collects, distributes and files regulatory documents.
Coordinate with IRB administrator to collect, review and maintain all IRB records.
Conduct quality assurance activities in preparation for regulatory audits by FDA, NIH, pharmaceuticals and others.
Prepare and submit documentation for regulatory bodies in support of clinical trials.
Reviews and recommends changes to clinical trial documents.
Review completed IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports and recommend changes.
Reviews and maintains trial related documents and operational procedures.
Review records of all protocols and study applications, safety reports, annual reports and correspondence for accuracy and completeness.
Review study protocols, and amendments, reviews, reports, and other necessary forms for accuracy and completeness.
Review for accuracy and submit study safety reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
Review for accuracy and completeness adverse event files and prepare reports in accordance with Institutional Review Board (IRB) processes and policies.
Collects, distributes and submits regulatory documents.
Conduct quality assurance activities in preparation for regulatory audits by FDA, NIH, pharmaceuticals and others.
Work with the Institutional Review Board (IRB) to keep abreast of new guidance related to protocol and informed consent submissions for both initial reviews and amendments
Develops training plans and trains staff on the proper techniques for protocol submission.