E-talentnetwork
Senior Clinical Protocol Coordinator
E-talentnetwork, Bethesda, Maryland, us, 20811
Position Requirements
Overall Position Summary and Objectives
Min Education
Resume Max Pages
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). Master's 3 Additional Qualifications Certifications & Licenses
GMP Certified Skills (Ranked By Priority)
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 1, 2, 3, 4, 5
represents priority rankings, where 1 is highest priority and 5 is lowest priority of those ranked Software
Clinical Trial Management System (CTMS) REDCap CAPA Microsoft Projects/Office NDA Filing RedCap Field of Study
Pharmacy Pharmaceutical Sciences and Administration
Statement of Work Details ssists researchers with protocol development, assembly and review of clinical trial documents.
ssist researchers prepare study reports and status updates, including amendments, audits and other administrative documentation. ssists researchers develop and maintain trial related documents and operational procedures.
ssist researchers write and edit study protocols, and prepare amendments, reviews, reports, and other necessary forms. Maintains study databases and conducts basic analysis.
ssist researchers track study requests and protocol approvals, maintaining a record of all submissions and status of approvals. ssist researchers prepare, review and submit clinical data to monitoring agencies. ssists researchers collect, distribute and file regulatory documents.
- Assist IRB administrator collect, review and maintain all IRB records.
ssist 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. ssist researchers prepare and communicate with IRB and NIH Clinical Center for protocol approval. ssist 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 protocollifecycle, 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 initialsubmissions, 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 andcompleteness. 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, informationrequests, 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.
Coordinate with IRB administrator to collect, review and maintain all IRB records.
4 Conduct quality assurance activities in preparation for regulatory audits by FDA, NIH, pharmaceuticals and others. Communicate with IRB and NIH Clinical Center for protocol approval.
3 Prepare and submit documentation for regulatory bodies in support of clinical trials.
2 Manage, track and report regulatory activities for all assigned protocols, from conception and development, through the protocollifecycle, to study closure.
5 Work with the Institutional Review Board (IRB) to keep abreast of new guidance related to protocol and informed consent submissionsfor both initial reviews and amendments, Develops training plans and trains staff on the proper techniques for protocol submission.
Educate research staff regarding relevant aspects of regulatory process including requirements of protocol development, conductof research trials, regulatory change, IRB and FDA submission requirements, radiation safety requirements, ethics clearances, and technology transfer.
1
Deliverables Meet with lab members to present updates - WeeklyWork products related to document reviews by the specified deadlines WeeklyWork products and communication related to meeting preparation and follow up activities, including preparing spreadsheets, letters, rosters, agendas, presentations, managing calendars and meeting minutes/summaries - WeeklyWork 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
Physical Requirements Does this position require enrollment in the NIH Bio surety Program?
Does this position have clinical responsibilities that involve direct patient care?
No No
Will the individual be required to:
Lift or carry more than 50 pounds
Lift or carry 25-50 pounds
Lift or carry less than 25 pounds
Push or pull more than 45 pounds
Push or pull 25-45 pounds
Reach above shoulder level
No No No No No Yes
Push or pull less than 25 pounds
Stand or walk more than 25 of 30 min
Bend repeatedly
Kneel
Crawl
Climb
No No No No No No
Have correctable near vision
Distinguish basic colors
Operate a motor vehicle
Perform repetitive activities
Have depth perception
Use both hands
No No No No No Yes
Will the individual be working:
lone
Closely with others
Outside
In dust
In excessive heat
In excessive cold
In excessive noise
No Yes No No No No No
Shifts
Protracted or irregular Hours
On slippery or uneven working surfaces
On ladders or scaffolding
round machinery with moving parts
With hands in water
With solvents
No No No No No No No
Will the individual be in contact with any of the following:
sbestos
High noise levels
Small animals (fish, birds, rodents etc.)
Large animals (cats, dogs, sheep etc.)
Non-Human primates (rhesus, cynos etc.)
Non-Human primate tissues
Radiation
Human blood or other body fluids
Patient/ Human subjects
Lasers (Open or Closed)
No No No No No No No No No No
Will the individual have contact with any of the following:
HIV-1
HIV-2
HTLV I/II
MMR Viruses
Rabies Virus
SIV
Taxoplasmosis
Varicella Virus
Orthopox Virus
No No No No No No No No No
Will the individual have contact with any of the following:
erosols
Biological Inhalants
Corrosive Substances
Inorganic dusts and powders
Insecti/Herbi/ Pesticides
Other
Plastics
Heavy Metals
Petroleum products
Solvents
Sensitizing Agents
No No No No No No No No No No No
Will the individual have contact with any of the following:
B.Antharcis
Botulinum N-toxin
Ebola Virus
F.talarensis
Monkeypox Virus
Ricin
Yersinia Pets
Other
No No No No No No No No
Will the individual have contact with any of the following Tier1 Select Agents:
Gloves
Face shields/ goggles
Safety Glasses
Safety Shoes
Lab Coat
Ear plugs/ muffs
Impervious suit
Disposable dust/surgical masks
Respirator
Clean Room Uniform
No No No No No No No No No No
Min Education
Resume Max Pages
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). Master's 3 Additional Qualifications Certifications & Licenses
GMP Certified Skills (Ranked By Priority)
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 1, 2, 3, 4, 5
represents priority rankings, where 1 is highest priority and 5 is lowest priority of those ranked Software
Clinical Trial Management System (CTMS) REDCap CAPA Microsoft Projects/Office NDA Filing RedCap Field of Study
Pharmacy Pharmaceutical Sciences and Administration
Statement of Work Details ssists researchers with protocol development, assembly and review of clinical trial documents.
ssist researchers prepare study reports and status updates, including amendments, audits and other administrative documentation. ssists researchers develop and maintain trial related documents and operational procedures.
ssist researchers write and edit study protocols, and prepare amendments, reviews, reports, and other necessary forms. Maintains study databases and conducts basic analysis.
ssist researchers track study requests and protocol approvals, maintaining a record of all submissions and status of approvals. ssist researchers prepare, review and submit clinical data to monitoring agencies. ssists researchers collect, distribute and file regulatory documents.
- Assist IRB administrator collect, review and maintain all IRB records.
ssist 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. ssist researchers prepare and communicate with IRB and NIH Clinical Center for protocol approval. ssist 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 protocollifecycle, 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 initialsubmissions, 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 andcompleteness. 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, informationrequests, 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.
Coordinate with IRB administrator to collect, review and maintain all IRB records.
4 Conduct quality assurance activities in preparation for regulatory audits by FDA, NIH, pharmaceuticals and others. Communicate with IRB and NIH Clinical Center for protocol approval.
3 Prepare and submit documentation for regulatory bodies in support of clinical trials.
2 Manage, track and report regulatory activities for all assigned protocols, from conception and development, through the protocollifecycle, to study closure.
5 Work with the Institutional Review Board (IRB) to keep abreast of new guidance related to protocol and informed consent submissionsfor both initial reviews and amendments, Develops training plans and trains staff on the proper techniques for protocol submission.
Educate research staff regarding relevant aspects of regulatory process including requirements of protocol development, conductof research trials, regulatory change, IRB and FDA submission requirements, radiation safety requirements, ethics clearances, and technology transfer.
1
Deliverables Meet with lab members to present updates - WeeklyWork products related to document reviews by the specified deadlines WeeklyWork products and communication related to meeting preparation and follow up activities, including preparing spreadsheets, letters, rosters, agendas, presentations, managing calendars and meeting minutes/summaries - WeeklyWork 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
Physical Requirements Does this position require enrollment in the NIH Bio surety Program?
Does this position have clinical responsibilities that involve direct patient care?
No No
Will the individual be required to:
Lift or carry more than 50 pounds
Lift or carry 25-50 pounds
Lift or carry less than 25 pounds
Push or pull more than 45 pounds
Push or pull 25-45 pounds
Reach above shoulder level
No No No No No Yes
Push or pull less than 25 pounds
Stand or walk more than 25 of 30 min
Bend repeatedly
Kneel
Crawl
Climb
No No No No No No
Have correctable near vision
Distinguish basic colors
Operate a motor vehicle
Perform repetitive activities
Have depth perception
Use both hands
No No No No No Yes
Will the individual be working:
lone
Closely with others
Outside
In dust
In excessive heat
In excessive cold
In excessive noise
No Yes No No No No No
Shifts
Protracted or irregular Hours
On slippery or uneven working surfaces
On ladders or scaffolding
round machinery with moving parts
With hands in water
With solvents
No No No No No No No
Will the individual be in contact with any of the following:
sbestos
High noise levels
Small animals (fish, birds, rodents etc.)
Large animals (cats, dogs, sheep etc.)
Non-Human primates (rhesus, cynos etc.)
Non-Human primate tissues
Radiation
Human blood or other body fluids
Patient/ Human subjects
Lasers (Open or Closed)
No No No No No No No No No No
Will the individual have contact with any of the following:
HIV-1
HIV-2
HTLV I/II
MMR Viruses
Rabies Virus
SIV
Taxoplasmosis
Varicella Virus
Orthopox Virus
No No No No No No No No No
Will the individual have contact with any of the following:
erosols
Biological Inhalants
Corrosive Substances
Inorganic dusts and powders
Insecti/Herbi/ Pesticides
Other
Plastics
Heavy Metals
Petroleum products
Solvents
Sensitizing Agents
No No No No No No No No No No No
Will the individual have contact with any of the following:
B.Antharcis
Botulinum N-toxin
Ebola Virus
F.talarensis
Monkeypox Virus
Ricin
Yersinia Pets
Other
No No No No No No No No
Will the individual have contact with any of the following Tier1 Select Agents:
Gloves
Face shields/ goggles
Safety Glasses
Safety Shoes
Lab Coat
Ear plugs/ muffs
Impervious suit
Disposable dust/surgical masks
Respirator
Clean Room Uniform
No No No No No No No No No No