Clinical Research Protocol Navigator - BETHESDA, United States - Guidehouse

Description

Job Family
:
Clinical Trial Operations (Digital)


Travel Required
:
None


Clearance Required
:
Ability to Obtain Public Trust


What You Will Do
:
We are currently searching for a Clinical Research Protocol Navigator.

The primary role for this Protocol Navigator (PN) position is 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 role is centered around clinical research protocol and informed consent document development and requires expert writing skills. This role also includes IRB submissions, regulatory document management, amongst other regulatory study tasks. This is a full-time opportunity located in Bethesda, MD.

• 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.
• 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.
• 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.
• 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.
• 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.
• 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 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.
• 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.

What You Will Need
:

• Master's Degree in any of the following: 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, or Miscellaneous Biology.
• Minimum of Two (2) years of experience in a clinical trial or clinical research setting.
• A certification in any of the following: 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), or Certified Clinical Research Associate (CCRA)
• Liaising with regulatory authorities
• Training clinical trial site staff
• Previous clinical trial work
• Phases I or II experience.
• Regulatory compliance, Protocol development, or Protocol navigation
• Regulatory affairs
• IRB submissions
• On-site visits
• Electronic Medical Records System
• Electronic Data Capture System

What Would Be Nice To Have
:

• PhD Degree Preferred

What We Offer:

Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.

Benefits include:

• Medical, Rx, Dental & Vision Insurance
• Personal and Family Sick Time & Company Paid Holidays
• Parental Leave
• 401(k) Retirement Plan
• Group Term Life and Travel Assistance
• Voluntary Life and AD&D Insurance
• Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts
• Transit and Parking Commuter Benefits
• Short-Term & Long-Term Disability
• Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities
• Employee Referral Program
• Corporate Sponsored Events & Community Outreach
• annual membership
• Employee Assistance Program
• Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)
• Position may be eligible for a discretionary variable incentive bonus

About Guidehouse
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 an accommodation, please contact Guidehouse Recruiting at or via email at .

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.

_