Global Solutions Network (GSN), a federal government contracting firm, presents this full time, long-term position supporting GSN's customer at the National Institutes of Health (NIH). This position provides a competitive salary and comprehensive benefits.

If interested, please provide an up-to-date resume.

Responsibilities.

• Develop and review completed new 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. 
• Develop new and review completed clinical research informed consent and other ethics and regulatory related documentation. 
• Prepare new and review completed study reports and status updates, including amendments, audits and other administrative documentation. 
• 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. 
• 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. 
• 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.
• Assist 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.
• 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.
• 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.
• Work with the NINDS Clinical Trials Unit CTU and NINDS staff on the development and preparation of standard operating procedures SOPs pertaining to protocol navigation and regulatory writing for the NINDS Intramural Research Program.
• Prepare draft documents for senior staff review.
• Coordinate with other offices e.g., Office of Human Subjects Research Protections, Office of Regulatory Support and Compliance, NINDS and NIH offices involved in communication to integrate and ensure consistency of new/revised documents with policies.
• Collaborate with NIH clinical research scientists, Principal Investigators, Research Coordinators, Protocol Navigators, NINDS Sponsor representatives, CTU staff, and safety, regulatory, and monitoring entities.
• Attend in-person meetings located at the NIH campus in Bethesda or virtual meetings, including weekly CTU staff meetings, protocol development meetings, research coordinator forum meetings, as well as regular research team meetings.
• 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.
• Collect, organize and maintain all study documentation to include investigator qualifications, trial logs, and safety reports.
• Maintain accurate records of all protocols and study applications, safety reports, annual reports and correspondence.
• Write and edit study protocols, and amendments, reviews, reports, and other necessary forms.
• 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.
• 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 audits by FDA, NIH, pharmaceuticals and others.
• 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.
• Develop new and review completed internal research proposals, abstract submissions, poster presentations and manuscript drafts.
• Collects, distributes and files regulatory documents.
• Develop and submit protocol actions for clearance within the NIH Protocol Tracking and Management System.
• 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.
• Prepare and submit documentation for regulatory bodies in support of clinical trials.
• Manage, track and report regulatory activities for all assigned protocols, from conception and development, through the protocol lifecycle, to study closure.
• 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.
• Develop and submit protocol actions for clearance within the NIH Protocol Tracking and Management System.
• 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.
• Prepare and submit documentation for regulatory bodies in support of clinical trials.
• Manage, track and report regulatory activities for all assigned protocols, from conception and development, through the protocol lifecycle, to study closure.
• 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.
• Maintain documentation of clinical research training of staff.
• Meet with investigators and advise them of the documentation and approvals they will need to initiate a clinical study based on the type, location and complexity of the proposal.
• 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.
• Organize regulatory protocol meetings and/or reports, as well as attend other research team staff meetings; interact closely with the research clinical team and other staff involved in protocol management; guide the protocol navigation process.

Qualifications.

• Certification related to Clinical Research
• Degree in Biological Sciences, Biomedical Research or Clinical/Health Professions or related area.
• Familiarity with the following software:
  • Clinical Trial Management System (CTMS)
  • Electronic Medical Records System 
  • Electronic Data Capture System
• Demonstrated experience in:
  • Liaising with regulatory authorities 
  • Training clinical trial site staff
  • Previous clinical trial work 
  • Phase I or II trials
  • Regulatory compliance
  • Protocol development
  • Protocol navigation
  • Regulatory affairs
  • Clinical Research
  • IRB submissions
  • Clinical Trials
  • On-site visits 
  • Data Integrity
  • ICH/GCP
  • Strong writing skills with experience writing clinical research protocols

Global Solutions Network, Inc. (GSN) is an Equal Employment Opportunity (EEO) employer. It is the policy of the GSN to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected US veteran or disabled status, or genetic information.