Clinical Research Operations Specialist
20 hours ago
**About the Role**
A Clinical Research Operations Specialist is needed to provide clinical research regulatory support through the NINDS Clinical Trials Unit (CTU) for the NINDS Intramural Research Program.
This role is centered around clinical research protocol and informed consent document development, requiring expert writing skills. The specialist will develop and review completed new and amended clinical research protocols and related documentation throughout the lifecycle of the study, ensuring accuracy, consistency, and completeness of documents.
The specialist will also prepare new and review completed study reports and status updates, including amendments, audits, and other administrative documentation. Additionally, they will develop and review completed IND and IDE safety, clinical study reports, and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.
Maintaining all regulatory trial documentation, including a complete and up-to-date Regulatory Binder for each trial, documentation of investigator qualifications, trial logs, and safety reports, is a crucial aspect of this role. The specialist will assist researchers with protocol development, assembly, and review of clinical trial documents, as well as develop and maintain trial-related documents and operational procedures.
Responsibilities include maintaining study databases, conducting basic analysis, assisting researchers in reviewing and submitting protocol actions for clearance within the NIH Protocol Tracking and Management System, and working 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.
**What You'll Need**
- A Master's Degree or higher
- A minimum of TWO (2) years of experience in a clinical trial or clinical research setting
- 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
- Previous experience in training clinical trial site staff
- Phases I or II experience and/or regulatory compliance experience
- Protocol development and protocol navigation knowledge
- Previous experience with a Clinical Trial Management System (CTMS), Electronic Medical Records System, and/or Electronic Data Capture System
**Salary Range**
$75,800.00-$113,600.00 per annum
**Benefits**
Guidehouse offers a comprehensive total rewards package that includes competitive compensation and a flexible benefits package. This package reflects Guidehouse's commitment to creating a diverse and supportive workplace. Benefits include medical, dental, and 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, and supplemental benefits via Corestream.
-
Clinical Research Nurse Specialist
19 hours ago
Bethesda, Maryland, United States Guidehouse Full timeJob SummaryWe are seeking a highly skilled Clinical Research Nurse Specialist to join our team at Guidehouse. The ideal candidate will have a strong background in nursing and clinical research, with experience in patient recruitment and data collection. The Clinical Research Nurse Specialist will work closely with our team to design and implement clinical...
-
Clinical Research Nurse
1 month ago
Bethesda, Maryland, United States Cape Fox Shared Services Full timeCape Fox Shared Services is seeking a highly skilled Clinical Research Nurse to join our team at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Requirements: Master's Degree in Nursing. Minimum of 5 years' experience in a clinical setting. Experience in evaluating pediatric patients with neurodevelopmental...
-
Clinical Research Physician Leader
2 days ago
Bethesda, Maryland, United States National Cancer Institute Full timeExciting Opportunity at the National Cancer InstituteWe are seeking a highly skilled Clinical Research Physician to join our team at the National Cancer Institute (NCI). This is an exceptional opportunity for physicians with an interest in translating bench-to-bedside research to clinical trials.The Women's Malignancies Branch (WMB) focuses on developing...
-
Clinical Research Nurse Practitioner
21 hours ago
Bethesda, Maryland, United States Henry M. Jackson Foundation for the Advancement of Military Medicine Full timeJob OverviewWe are seeking a highly skilled Clinical Research Nurse Practitioner to join our team at the Henry M. Jackson Foundation for the Advancement of Military Medicine.About UsThe Henry M. Jackson Foundation for the Advancement of Military Medicine is a 501(c)(3) nonprofit organization dedicated to advancing military medicine. We serve military,...
-
Clinical Neuropsychologist Specialist
36 seconds ago
Bethesda, Maryland, United States Akahi Associates, LLC Full timeJob Opportunity: We are seeking a highly skilled Clinical Neuropsychologist to join our team at Akahi Associates, LLC.About the Role: As a Clinical Neuropsychologist, you will be responsible for providing expert support services to satisfy the operational objectives of the National Institute of Mental Health.Key Responsibilities:Provides screening and...
-
Research Assistant I
1 month ago
Bethesda, Maryland, United States Henry M. Jackson Foundation for the Advancement of Military Medicine Full timeAbout the RoleWe are seeking a highly motivated and detail-oriented Research Assistant I to join our team at the Henry M. Jackson Foundation for the Advancement of Military Medicine. As a Research Assistant, you will play a critical role in supporting our research projects, working closely with senior technical and professional staff to carry out research...
-
Research and Development Specialist
2 days ago
Bethesda, Maryland, United States Henry M. Jackson Foundation for the Advancement of Military Medicine Full timeJob Overview: The Henry M. Jackson Foundation for the Advancement of Military Medicine is seeking a highly skilled Research Assistant I or II to collaborate on research projects in collaboration with others supporting the laboratory of Dr. Irwin Lucki with the Department of Pharmacology at the Uniformed Services University in Bethesda, MD.
-
Clinical Nursing Specialist
1 month ago
Bethesda, Maryland, United States Zimmerman Associates Full timeJob Title: Clinical Nursing SpecialistZimmerman Associates, Inc. (ZAI) is seeking a Clinical Nursing Specialist to support a government contract bid in the Bethesda, MD area. This is an onsite employment opportunity, with consideration for teleworking upon customer approval.Role and Responsibilities:Review referrals for suitability, administrative and...
-
Research Assistant II
1 month ago
Bethesda, Maryland, United States Henry M. Jackson Foundation for the Advancement of Military Medicine Full timeJob Title: Research Assistant IIWe are seeking a highly motivated and detail-oriented Research Assistant II to join our team at the Henry M. Jackson Foundation for the Advancement of Military Medicine. The successful candidate will provide laboratory and technical support to senior technical and professional staff, and will be responsible for solving...
-
Clinical Nurse Specialist
3 hours ago
Bethesda, Maryland, United States beBee Professionals Full time $60,000 - $80,000Overview">At beBee Professionals, we are seeking a highly skilled Clinical Nurse Specialist to join our team in Bethesda. This role involves providing exceptional nursing care in various healthcare settings.">Key Responsibilities">To deliver comprehensive nursing care to patients with diverse needs.To collaborate with multidisciplinary teams to develop and...
-
Research Assistant I
1 month ago
Bethesda, Maryland, United States Henry M. Jackson Foundation for the Advancement of Military Medicine Full timeJob SummaryWe are seeking a highly skilled Research Assistant I to join our team at the Henry M. Jackson Foundation for the Advancement of Military Medicine. The successful candidate will provide genomics support to investigators, technical personnel, and students, and will be responsible for operating and maintaining genomics facility instrumentation.Key...
-
Bethesda, Maryland, United States Henry M. Jackson Foundation for the Advancement of Military Medicine Full timePostdoctoral Research Fellow in PharmacoepidemiologyWe are seeking a highly motivated Postdoctoral Research Fellow to join our team in the Department of Medical and Clinical Psychology at Uniformed Services University. The successful candidate will be responsible for conducting mentored research in pharmacoepidemiology, focusing on deriving real-world...
-
Senior Data Operations Manager, DCC
1 month ago
Bethesda, Maryland, United States Henry M. Jackson Foundation for the Advancement of Military Medicine Full timeJob SummaryThe Henry M. Jackson Foundation for the Advancement of Military Medicine is seeking a Senior Data Operations Manager, Data Coordination Center to assist the Chief of Data Operations in overseeing and ensuring accountability for all clinical data management activities within Infectious Disease Clinical Research Program's (IDRCP) Data Coordination...
-
Postdoctoral Research Associate
22 hours ago
Bethesda, Maryland, United States Henry M. Jackson Foundation for the Advancement of Military Medicine Full timeOverviewThe Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine through preeminent scientific programs.Salary and BenefitsWe offer an annual salary in the range of $50,100-$64,000 based on experience and education. The position will be hired through HJF, which...
-
Financial Operations Specialist
12 minutes ago
Bethesda, Maryland, United States ISN Corporation Full timeAbout the RoleISN Corporation, a leading provider of professional services to Federal government agencies and commercial clients, seeks an experienced Financial Operations Specialist to join our team.This is an exciting opportunity to leverage your expertise in financial management and accounting software to drive business growth and success. The ideal...
-
Senior Genomics Research Assistant
21 hours ago
Bethesda, Maryland, United States Henry M. Jackson Foundation for the Advancement of Military Medicine Full timeCompany Overview: Henry M. Jackson Foundation for the Advancement of Military Medicine is a 501(c)(3) nonprofit organization dedicated to advancing military medicine.">About Us: We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and...
-
Grocery Operations Specialist
1 week ago
Bethesda, Maryland, United States Giant Food Full timeAbout the Role:At Giant Food, we're seeking a skilled Grocery Operations Specialist to join our dynamic team. As a key member of our store operations, you will play a vital role in ensuring seamless customer experiences.Key Responsibilities:Bundling and pricing groceries to the highest standards.Providing exceptional customer service, addressing queries and...
-
Radiation Oncology Specialist
18 hours ago
Bethesda, Maryland, United States Johns Hopkins HealthCare Full timeRadiation Therapist Opportunity at Johns Hopkins Health SystemSuburban Hospital, part of the esteemed Johns Hopkins Health System, offers unparalleled access to cutting-edge cancer care provided by a multidisciplinary team of specialists in medical oncology, radiation oncology, and surgical oncology. Our Radiation Oncology department utilizes advanced...
-
Executive Administrative Specialist
20 hours ago
Bethesda, Maryland, United States Fidelity Partners Full timeRole Summary:We are seeking an Executive Administrative Specialist to join our team at Fidelity Partners. As an Executive Administrative Specialist, you will play a key role in providing administrative support to senior officials and staff, ensuring seamless day-to-day operations, and contributing to the success of our organization.About Us:Fidelity Partners...
-
Healthcare Support Specialist
19 hours ago
Bethesda, Maryland, United States American Oncology Management Company Full timeAbout the RoleThe Patient Services Specialist will play a vital role in ensuring the smooth operation of our clinic's daily activities. This includes checking in patients, verifying demographic information, and accurately recording payments.The ideal candidate will possess excellent organizational and time management skills, with the ability to prioritize...