Axle · 18 hours ago
Senior Clinical Protocol Coordinator
Bethesda, MD
Full-time
Onsite
Mid, Senior Level
$120K/yr - $130K/yrAxle 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. The Senior Clinical Protocol Coordinator will provide support services to the National Institute of Dental and Craniofacial Research (NIDCR), focusing on clinical research operations and regulatory compliance.
BiotechnologyHealth CareInformation TechnologySoftware
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. - 1
Prepare and submit documentation for regulatory bodies in support of clinical trials. - 2
Communicate with IRB and NIH Clinical Center for protocol approval. - 3
Coordinate with IRB administrator to collect, review and maintain all IRB records. - 4
Manage, track and report regulatory activities for all assigned protocols, from conception and development, through the protocol lifecycle, to study closure. - 5
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
Qualification
Required
Masters
GMP Certified
Field of Study: 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
Benefits
100% Medical, Dental & Vision Coverage for Employees
Paid Time Off and Paid Holidays
401K match up to 5%
Educational Benefits for Career Growth
Employee Referral Bonus
Flexible Spending Accounts:
Healthcare (FSA)
Parking Reimbursement Account (PRK)
Dependent Care Assistant Program (DCAP)
Transportation Reimbursement Account (TRN)
Company
Axle
At Axle, we are driven by the mission to accelerate discovery and enhance organizational outcomes by revolutionizing operations with our innovative solutions.
Founded in 2002
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Gary Mays
Chief Operating Officer
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