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Clinical Research Protocol Navigator

Employer
Medical Science & Computing (MSC), a Dovel company
Location
Bethesda, Maryland
Start date
Jul 30, 2022

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Discipline
Clinical, Clinical Research, Regulatory
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
BioCapital
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Job Details

We are currently searching for a Clinical Research Protocol Navigator to provide clinical research regulatory support through the NINDS Clinical Trials Unit (CTU) for the NINDS Intramural Research Program, including specific groups as assigned. This is a full-time, on-site opportunity in Bethesda, MD.  

Duties & Responsibilities
  • Develop/prepare new and review completed:
    • protocol documentation including schemas, patient calendars and teaching aids.
    • 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.
    • IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
    • develop new and review completed internal research proposals, abstract submissions, poster presentations and manuscript drafts.
  • Develop and submit protocol actions for clearance within the NIH Protocol Tracking and Management System.
  • Develop clinical research informed consent and other ethics and regulatory related documentation description.
  • 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.
  • 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.
  • Track and review adverse event files and prepare reports in accordance with Institutional Review Board IRB processes and policies.
  • 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.
  • Organize quality assurance activities with pertinent regulatory bodies such as FDA, NIH, pharmaceuticals, and others.
  • Assist researchers:
    • develop, prepare internal research proposals, abstract submissions, poster presentations and manuscript drafts.
    • develop protocol documentation including schemas, patient calendars and teaching aids.
    • develop clinical research informed consent and other ethics and regulatory related documentation.
    • prepare study reports and status updates, including amendments, audits, and other administrative documentation.
    • 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 prepare amendments, reviews, reports, and other necessary forms.
    • prepare and submit study safety reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
    • track and review adverse event files and report events in accordance with Institutional Review Board IRB processes and policies.
    • track study requests and protocol approvals, maintaining a record of all submissions and status of approvals.
    • prepare, review, and submit clinical data to monitoring agencies.
    • review and submit protocol actions for clearance within the NIH Protocol Tracking and Management System.
    • prepare and communicate with IRB and NIH Clinical Center for protocol approval.
    • prepare submissions to regulatory bodies in support of clinical trials.
  • Prepare:
    • draft documents for senior staff review.
    • study reports and status updates, including amendments, audits, and other administrative documentation.
    • IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
    • and support submission of study safety reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
    • researcher communication with IRB and NIH Clinical Center for protocol approval.
    • submission documentation for regulatory bodies in support of clinical trials.
  • 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.
  • 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.
    • Maintain all study documentation to include investigator qualifications, trial logs, and safety reports and review for accuracy and completeness.
    • 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.
    • Maintain documentation of clinical research training of staff.
  • Organize quality assurance activities with pertinent regulatory bodies such as audits by FDA, NIH, pharmaceuticals, and others.
  • Manage, track, and coordinate regulatory activities for all assigned protocols, from conception and development, through the protocol lifecycle, to study closure.
  • 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.
  • 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.
    • clinical research informed consent and other ethics and regulatory related documentation and recommend changes.
    • standard operating procedures SOPs for the clinical study and recommend changes.
    • study reports and status updates, including amendments, audits and other administrative documentation and recommend changes.
    • IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports and recommend changes.
  • Review for accuracy and completeness:
    • all protocols and study applications, safety reports, annual reports and correspondence for accuracy and completeness
    • study protocols, and amendments, reviews, reports, and other necessary forms for accuracy and completeness
    • submit study safety reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
    • 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.
  • 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.
  • 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.
  • 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.
  • 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.

 

#SOAR

#LI-FG1

Requirements

 

Qualifications:

  • Master’s degree in Nursing, Biology, General Science, Health and Medical Preparatory Programs, General Medical and Health Services, Neuroscience, Health and Medical Administrative Services, Cognitive Science and Biopsychology, or related disclipine
  • At least 1 year of experience
  • Preferred professional memberships:
    • 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)

 

Skills:

  • Protocol navigation
  • IRB submissions
  • Protocol writing
  • ICH/GCP
  • Liaising with regulatory authorities
  • Training clinical trial site staff
  • Previous clinical trial work
  • Phase I or II experience
  • Regulatory compliance
  • Protocol development
  • Regulatory affairs
  • Clinical Research
  • Clinical Trials
  • On-site visits
  • Data Integrity
  • Research
  • Clinical Trial Management System (CTMS)
  • Electronic Medical Records System
  • Electronic Data Capture System

 

Company Description

Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.

 

Guidehouse is a leading global provider of consulting services to the public sector and commercial markets, with broad capabilities in management, technology, and risk consulting. By combining our public and private sector expertise, we help clients address their most complex challenges and navigate significant regulatory pressures focusing on transformational change, business resiliency, and technology-driven innovation. Across a range of advisory, consulting, outsourcing, and digital services, we create scalable, innovative solutions that help our clients outwit complexity and position them for future growth and success. The company has more than 12,000 professionals in over 50 locations globally. Guidehouse is a Veritas Capital portfolio company, led by seasoned professionals with proven and diverse expertise in traditional and emerging technologies, markets, and agenda-setting issues driving national and global economies.

 

Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.

 

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance, including the Fair Chance Ordinance of Los Angeles and San Francisco.

 

If you have visited our website for information about employment opportunities or to apply for a position, and you require accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

 

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse, and Guidehouse will not be obligated to pay a placement fee.

 

 

Company

Medical Science & Computing (MSC), a Dovel company, is a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. The Dovel Family of Companies combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management. 

MSC has long supported Federal health organizations like the National Institutes of Health (NIH) and applies deep understanding of missions, goals, and operations to discover and implement innovative approaches for streamlining and disseminating research efforts, enhancing knowledge sharing, and improving public health. 

Together, Dovel and MSC offer a diverse set of complex biomedical, scientific, and technology services, coupled with attentive and purpose-driven program management to serve mission critical organizations and drive meaningful change in the world.

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Website
Location
11300 Rockville Pike Suite 1100
Rockville
MD
20852
United States
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