- 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.
- 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.
- At least (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
- Strong writing skills with experience writing clinical research protocols.
- Experience with the following Systems: Clinical Trial Management System (CTMS), Electronic Medical Records System, Electronic Data Capture System
- PhD Degree Preferred
- 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
-
Clinical Research Protocol Navigator
1 week ago
Axle Rockville, United States**Axle** is seeking a **_Clinical Research Protocol Navigator _**to join our vibrant team at the National Institutes of Health (NIH) supporting the **National Institute of Neurological Disorders and Stroke (NINDS) located in Bethesda, MD.** · **Benefits We Offer**: · - 100% Medic ...
-
Clinical Research Protocol Navigator
1 week ago
Guidehouse Bethesda, United StatesJob 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) positi ...
-
Clinical Research Protocol Navigator
1 week ago
Veear Projects Inc Bethesda, United StatesWork Details: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 ...
-
Clinical Research Protocol Navigator
1 week ago
VeeAR Projects Inc. Bethesda, United StatesWork Details: · 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 clinic ...
-
Clinical Research Protocol Navigator
1 week ago
Axle Rockville, United StatesJob Description · Job Description: · (ID: Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With ...
-
Non-profit Administrative Manager
1 week ago
CoachCruiting Silver Spring, United States**MESH Charities**, located in Silver Spring, MD is a non-profit organization founded in 1902. We strive to provide humanitarian relief for eligible individuals and their families in the transition through the final phase of life. The individual we are seeking must display empath ...
-
Administrative Manager
1 week ago
CoachCruiting Silver Spring, United States**MESH Charities**, located in Silver Spring, MD is a non-profit organization founded in 1902. We strive to provide humanitarian relief for eligible individuals and their families in the transition through the final phase of life. The individual we are seeking must display empath ...
-
Traffic Control Technician
1 week ago
Buyers Barricades - Houston Spring, United StatesTexas roads are hazardous. And we help keep them safe. · It is our mission to make job sites safer for everyone, ensuring every employee and customer makes it home. We take pride in the work we do and value each person on our roster. We are looking for someone who takes their wor ...
-
Student Program Coordinator, Basic Needs
1 week ago
George Washington University Foggy Bottom, United States**Posting Details**: · - I. JOB OVERVIEW**Job Description Summary**: · - The Division for Student Affairs (DSA) interacts with students throughout all phases of the student lifecycle. DSA's integrated approach is to provide a cohesive student experience built upon three core valu ...
-
Supervising Navigator
1 week ago
The Fedcap Group Washington, United States**Position Summary**: · The Supervisor for, DC Career MAP Workforce Development program will supervise a team of Navigators' (case management staff) and support staff in their daily functions ensuring full departmental adherence to policy and protocol serve, as well as serving as ...
-
Nurse Navigator
1 week ago
AMR Washington, United States**Job Description**: · We invite you to join a team of highly skilled emergency medical experts, pilots and mechanics Our mission of providing care to the world at a moment's notice is at the heart of everything we do. We are caregivers, first and foremost and we will be there wh ...
-
Nurse Navigator
1 week ago
MEDSTAR HEALTH Washington, United States**General Summary of Position** · The Nurse Navigator is responsible for the coordination of patient care across the continuum under the auspices of a provider's prescribed plan of care, national guidelines, and within the scope of nursing practice. The navigator educates/provide ...
-
Associate - Public Affairs
1 week ago
Dentons Global Advisors Washington, United States**Location** · Washington, DC (hybrid, with a minimum of three (3) days per week in the office) · **Responsibilities** · - Work directly with and learn from a group of senior experts within a flat organizational structure · - Be part of a core team focused on advising companies a ...
-
Limousine Driver
1 week ago
Bankers Business Management Services, Inc. Washington, United StatesJob Summary: · We are seeking a reliable and professional Limousine Driver to join our team. As a Limousine Driver, you will be responsible for providing safe and efficient transportation services to our clients. This is a great opportunity for individuals with excellent customer ...
-
React Js Developer
1 week ago
RogueThink Washington, United StatesJob Brief · · · · · Roles and Responsibilities · · - Collaborating with the tech lead to design and document the sub-module. · - Implement the module's crucial components into action. · - Ensure you adhere to coding standards, appropriate design patterns, developing tes ...
-
Anti-trafficking Hotline Advocate Full-time
5 days ago
Polaris Project Washington, United States Full time: · **Position**:Anti-Trafficking Hotline Advocate (Full-time) · **Department**:National Human Trafficking Hotline · **FLSA Status**: Full-time, Non-exempt · **Reports to**: Hotline Supervisor · **Date Revised: 4/24/2023** · **Location**: Washington, DC (Hybrid) · **The Mission** ...
-
Facility and Office Operations Manager
1 week ago
National Journal Washington, United StatesNational Journal is a premier research and insights company committed to helping organizations effectively navigate Washington. Best known as one of Washington's most trusted media brands for nearly 50 years, our expertise is unmatched with teams of specialists dedicated to gover ...
-
Director, Financial and Housing Policy
4 days ago
National Urban League Washington, United StatesOverview: · **The National Urban League seeks a dedicated Director, Financial and Housing Policy, to join our Washington Bureau, reporting directly to the Executive Director of the Washington Bureau. **The Director will design, develop, and implement policy programs within their ...
-
Associate Vice President, Data Science
3 days ago
The EMMES Corporation Rockville, United StatesOverview: · **Associate Vice President, Data Science & AI** · **US Remote** · Emmes Group: Building a better future for us all. · Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Gro ...
-
Delivery Associate Starts at
1 week ago
MVMT LLC Hyattsville, United StatesBecome a Delivery Associate with MVMT LLC · "Our only Delivery Station is located at 5801 Columbia Park Rd Hyattsville, MD 20785." · - Compensation: $19.50/hr_ · MVMT LLC is an Amazon Delivery Service Partner that is a proud black-owned and operated business in the DMV area for ...
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.What You Will Need
:
What Would Be Nice To Have
:
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:
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.
_