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Research Protocol Navigator
Bethesda, MD
Job Description
Job Title: Research Protocol Navigator
Location: Bethesda MD 20814
Duration: 3 Years to Permanent
Shift: Up to 40 Hours/Week
Teleworking Eligible: Yes
Min Education:
About our Company: -
22nd Century Technologies, Inc., is one of the fastest growing IT Service Integrator and Workforce Solution companies in the United States. Founded in 1997, 22nd Century Technologies is a Certified National Minority Business Enterprise with 6,000+ people including 600+ Cyber SMEs nationwide supporting our customers in all 50 states, Canada, and Mexico. With HQs in Somerset, NJ and Mclean, VA, 22nd Century has 14 offices throughout the United States. As part of our unrelenting focus on quality and compliance, 22nd Century Technologies’ delivery is based on Certified Matured Processes including CMMI L3 Dev & SVC, ISO 20000, ISO 27001, and ISO 9001 quality processes. With a strong focus on the public sector, 22nd Century currently holds government contracts with 14 out of 15 Federal Executive agencies including DoD, 37 other Federal agencies, 50 States, 115+ Local agencies, and 37 School Districts. In the last three years, we have expanded our services to Fortune 500 and other commercial clients and currently support 80+ commercial clients.
Recognized among “Best Company to Work For” by Forbes, 22nd Century Technologies, Inc., consistently exceeds our clients’ expectations by focusing on their absolute satisfaction with jobs while keeping our employees motivated.
“22nd Century Technologies is an Equal Opportunity Employer" and “US Citizens & all other parties authorized to work in the US are encouraged to apply."
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Location: Bethesda MD 20814
Duration: 3 Years to Permanent
Shift: Up to 40 Hours/Week
Teleworking Eligible: Yes
Min Education:
- Master's
- Association of Clinical Research Professionals Certified
- Professional (ACRP-CP) - Association of Clinical Research
- Professionals (ACRP) - Certified Clinical Research
- Professional (CCRP) - Certified Clinical Research Coordinator
- (CCRC) - Certified Clinical Research Associate (CCRA)
- Miscellaneous Health Medical Professions.
- Nursing.
- Biology.
- Multi-Disciplinary or General Science.
- Health and Medical.
- Preparatory Programs.
- General Medical and Health Services.
- Neuroscience.
- Health and Medical Administrative Services.
- Cognitive Science and Biopsychology.
- Miscellaneous Biology.
- Clinical Trial Management System (CTMS).
- Electronic Medical Records System.
- Electronic Data Capture System.
- Liaising with regulatory authorities.
- Training clinical trial site staff
- Previous clinical trial work
- Phase I or II experience.
- Regulatory compliance.
- Protocol development.
- Protocol navigation.
- Regulatory affairs.
- Clinical Research.
- IRB submissions.
- Clinical.
- Trials.
- On-site visits.
- Data Integrity.
- Research.
- ICH/GCP Strong writing skills with experience writing clinical research protocols.
- Assist researchers develop, prepare internal research proposals, abstract submissions, poster presentations and manuscript drafts.
- Assist researchers develop protocol documentation including schemas, patient calendars and teaching aids.
- Assist researchers develop clinical research informed consent and other ethics and regulatory related documentation.
- Assist researchers prepare study reports and status updates, including amendments, audits and other administrative documentation.
- Assists researchers to develop initial and amended clinical research protocols and related documentation throughout the lifecycle of the study, with special attention to the accuracy, consistency, and completeness of documents.
- Assists researchers develop and maintain trial related documents and operational procedures.
- Assist researchers collect, organize and maintain all study documentation to include investigator qualifications, trial logs, and safety reports.
- Assist researchers maintain accurate records of all protocols and study applications, safety reports, annual reports and correspondence.
- Assist researchers write and edit study protocols, and prepare amendments, reviews, reports, and other necessary forms.
- Assist researchers prepare and submit study safety reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
- Assist researchers track and review adverse event files and report events in accordance with Institutional Review Board (IRB) processes and policies.
- Assist researchers collect, organize and maintain all study documentation to include investigator qualifications, trial logs, and safety reports.
- Assist researchers maintain accurate records of all protocols and study applications, safety reports, annual reports and correspondence.
- Assist researchers write and edit study protocols, and prepare amendments, reviews, reports, and other necessary forms.
- Assist researchers prepare and submit study safety reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
- Assist researchers track and review adverse event files and report events in accordance with Institutional Review Board (IRB) processes and policies.
- 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.
- Provides technical support to researchers and the clinic.
- Develops and assembles clinical trial documents.
- Develop protocol documentation including schemas, patient calendars and teaching aids.
- Prepare study reports and status updates, including amendments, audits and other administrative documentation.
- Prepare IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
- Develop clinical research informed consent and other ethics and regulatory related documentation description
- Collects and distributes regulatory documents.
- Develops, assembles and reviews clinical trial documents.
- Reviews and recommends changes to clinical trial documents.
- Review completed protocol documentation including schemas, patient calendars and teaching aids and recommend changes.
- Review completed clinical research informed consent and other ethics and regulatory related documentation and recommend changes.
- Review completed standard operating procedures (SOPs) for the clinical study and recommend changes.
- Review completed study reports and status updates, including amendments, audits and other administrative documentation and recommend changes.
- 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 clinical research protocols and related documentation throughout the developmental process, and prior to submission for accuracy, consistency, and completeness and recommends changes as needed.
- Maintain all study documentation to include investigator qualifications, trial logs, and safety reports and review for accuracy and completeness.
- 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.
- Maintain all regulatory trial documentation including maintaining a complete and up-to-date Regulatory Binder for each trial, documentation of investigator qualifications, trial logs and safety reports and review for accuracy and completeness.
About our Company: -
22nd Century Technologies, Inc., is one of the fastest growing IT Service Integrator and Workforce Solution companies in the United States. Founded in 1997, 22nd Century Technologies is a Certified National Minority Business Enterprise with 6,000+ people including 600+ Cyber SMEs nationwide supporting our customers in all 50 states, Canada, and Mexico. With HQs in Somerset, NJ and Mclean, VA, 22nd Century has 14 offices throughout the United States. As part of our unrelenting focus on quality and compliance, 22nd Century Technologies’ delivery is based on Certified Matured Processes including CMMI L3 Dev & SVC, ISO 20000, ISO 27001, and ISO 9001 quality processes. With a strong focus on the public sector, 22nd Century currently holds government contracts with 14 out of 15 Federal Executive agencies including DoD, 37 other Federal agencies, 50 States, 115+ Local agencies, and 37 School Districts. In the last three years, we have expanded our services to Fortune 500 and other commercial clients and currently support 80+ commercial clients.
Recognized among “Best Company to Work For” by Forbes, 22nd Century Technologies, Inc., consistently exceeds our clients’ expectations by focusing on their absolute satisfaction with jobs while keeping our employees motivated.
“22nd Century Technologies is an Equal Opportunity Employer" and “US Citizens & all other parties authorized to work in the US are encouraged to apply."
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Contact Information
Sandeep Gill |Hiring Manager sandeepg@tscti.com |O: 804-372-0705 Ext. 2130 |Cell: 804-429-3261
Job Summary
Employment Term and Type
Regular, Full Time
Salary and Benefits
$80k to $85k/Annually
Required Education
Master's Degree
Required Experience
Open
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