Senior Clinical Protocol Coordinator

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).

• 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.

Certifications & Licenses

• GMP Certified

Field of Study

• Pharmacy Pharmaceutical Sciences and Administration

Software

• Clinical Trial Management System (CTMS)
• REDCap
• CAPA
• Microsoft Projects/Office
• NDA Filing
• RedCap

Skills

• 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