Current jobs related to Clinical Protocol Coordinator - Bethesda - Cape Fox Corporation
-
Clinical Protocol Coordinator
3 months ago
Bethesda, United States Cape Fox Federal Contracting Group Full timeJob Description Concentric Methods is seeking a Clinical Protocol Coordinator to join our ream in Bethesda, MD in support of the NIH. Responsibilities: Assists researchers with protocol development, assembly and review of clinical trial documents. Assist researchers develop, prepare internal research proposals, abstract submissions, poster...
-
Clinical Research Protocol Specialist
1 week ago
Bethesda, Maryland, United States Axle Full timeJob OverviewAxle is a pioneering organization in the fields of bioscience and information technology, dedicated to enhancing translational research, biomedical informatics, and data science applications for research institutions and healthcare entities both domestically and internationally. Our team comprises specialists in biomedical science, software...
-
Clinical Research Protocol Specialist
1 week ago
Bethesda, Maryland, United States Guidehouse Full timeJob Family:Clinical Trial Operations (Digital)Travel Required:NoneClearance Required:Ability to Obtain Public TrustPosition Overview:We are seeking a Clinical Research Protocol Navigator to provide essential regulatory support for clinical research activities. This role is integral to the NINDS Clinical Trials Unit (CTU) and involves collaborating with...
-
Clinical Research Protocol Navigator
3 weeks ago
BETHESDA, United States Guidehouse Full timeJob Family:Clinical Trial Operations (Digital)Travel Required:NoneClearance Required:Ability to Obtain Public TrustWhat 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)...
-
Clinical Research Protocol Specialist
1 week ago
Bethesda, Maryland, United States Guidehouse Full timeJob Family:Clinical Trial Operations (Digital)Travel Required:NoneClearance Required:Ability to Obtain Public TrustRole Overview:We are seeking a Clinical Research Protocol Specialist to provide essential regulatory support for clinical research initiatives. The primary responsibility of this position is to facilitate the development of clinical research...
-
Protocol Nurse Coordinator II/III
3 weeks ago
Bethesda, United States Frederick National Laboratory for Cancer Research Full timeProtocol Nurse Coordinator II/III Job ID: req4058Employee Type: exempt full-timeDivision: Clinical Research ProgramFacility: NIHLocation: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by...
-
Protocol Nurse Coordinator II/III
3 weeks ago
Bethesda, Maryland, United States Frederick National Laboratory for Cancer Research Full timeProtocol Nurse Coordinator II/IIIJob ID: req4058Employee Type: exempt full-timeDivision: Clinical Research ProgramFacility: NIHLocation: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USAThe Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos...
-
Clinical Research Protocol Navigator
2 weeks ago
Bethesda, United States Guidehouse Full timeJob Family:Clinical Trial Operations (Digital)Travel Required:NoneClearance Required:Ability to Obtain Public TrustWhat You Will Do: 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...
-
Clinical Research Protocol Navigator
3 weeks ago
BETHESDA, United States Guidehouse Full timeJob Family:Clinical Trial Operations (Digital)Travel Required:NoneClearance Required:Ability to Obtain Public TrustWhat You Will Do: 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...
-
Clinical Research Protocol Specialist
1 week ago
Bethesda, Maryland, United States Guidehouse Full timeJob Family:Clinical Trial Operations (Digital)Travel Required:NoneClearance Required:Ability to Obtain Public TrustKey Responsibilities:We are seeking a Clinical Research Protocol Specialist to deliver regulatory support for clinical research through the NINDS Clinical Trials Unit (CTU) within the NINDS Intramural Research Program. This position focuses on...
-
Protocol Development Specialist
10 hours ago
Bethesda, Maryland, United States Cape Fox Federal Contracting Group Full timeJob SummaryCape Fox Federal Contracting Group is seeking a highly skilled Clinical Research Coordinator to join our team. As a Clinical Research Coordinator, you will play a critical role in the development and implementation of clinical research protocols.Key ResponsibilitiesProtocol Development: Assist researchers in the development of clinical research...
-
Protocol Navigator II
3 weeks ago
Bethesda, Maryland, United States Frederick National Laboratory for Cancer Research Full timeProtocol Navigator II - NHLBI (LOCAL/Remote)Job ID: req4053Employee Type: exempt full-timeDivision: Clinical Monitoring Research ProgramFacility: NIHLocation: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USAThe Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI)...
-
Protocol Navigator
4 weeks ago
Bethesda, United States Guidehouse Full timeJob Family: Administrative Services (Digital) Travel Required: None Clearance Required: Ability to Obtain Public Trust What You Will Do: We are currently searching for a Protocol Navigator to support the National Institutes of Health (NIH). This opportunity is full-time, on site in Bethesda, MD and may be eligible for telework after successful orientation. ...
-
Clinical Protocal Coordinator
4 weeks ago
Bethesda, United States Axle Full timeJob DescriptionJob Description(ID: 2024-5984)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 experts in biomedical science, software engineering, and program management,...
-
Protocol Navigator II
1 month ago
Bethesda, United States Frederick National Laboratory for Cancer Research Full timeProtocol Navigator II - NHLBI (LOCAL/Remote) Job ID: req4053 Employee Type: exempt full-time Division: Clinical Monitoring Research Program Facility: NIH Location: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National...
-
Protocol Navigator III
1 month ago
Bethesda, United States Frederick National Laboratory for Cancer Research Full timeProtocol Navigator III - NHLBI (LOCAL/remote) Job ID: req4054 Employee Type: exempt full-time Division: Clinical Monitoring Research Program Facility: NIH Location: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National...
-
Protocol Navigator III
3 weeks ago
Bethesda, United States Frederick National Laboratory for Cancer Research Full timeProtocol Navigator III - NHLBI (LOCAL/remote) Job ID: req4054Employee Type: exempt full-timeDivision: Clinical Monitoring Research ProgramFacility: NIHLocation: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute...
-
Protocol Navigator II
3 weeks ago
Bethesda, United States Frederick National Laboratory for Cancer Research Full timeProtocol Navigator II - NHLBI (LOCAL/Remote) Job ID: req4053Employee Type: exempt full-timeDivision: Clinical Monitoring Research ProgramFacility: NIHLocation: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute...
-
Clinical Study Coordinator II
3 weeks ago
Bethesda, Maryland, United States Frederick National Laboratory for Cancer Research Full timeClinical Study Coordinator II - LOCALJob ID: req4057Employee Type: exempt full-timeDivision: Clinical Research ProgramFacility: NIHLocation: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USAThe Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by...
-
Research Nurse Specialist
10 hours ago
Bethesda, Maryland, United States Guidehouse Full timeAbout the RoleWe are seeking a highly skilled Research Nurse Specialist to join our team at Guidehouse. As a key member of our clinical research team, you will be responsible for coordinating and implementing research protocols, managing data and study activities, and ensuring compliance with regulatory requirements.Key ResponsibilitiesProtocol Coordination:...
![Cape Fox Corporation](https://media.trabajo.org/img/noimg.jpg)
Clinical Protocol Coordinator
2 months ago
Share this job as a link in your status update to LinkedIn.
Job Title
Clinical Protocol Coordinator
Job Description
Concentric Methods is seeking a Clinical Protocol Coordinator to join our ream in Bethesda, MD in support of the NIH.
Responsibilities:
Assists researchers with protocol development, assembly and review of clinical trial documents.
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.
Assists researchers develop and maintain trial related documents and operational procedures.
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.
Maintains study databases and conducts basic analysis.
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.
Assists researchers collect, distribute and file regulatory documents.
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.
Provides technical support to researchers and the clinic.
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 eg, 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
Develops and assembles clinical trial documents.
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
Develops and maintains trial related documents and operational procedures.
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.
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.
Collects and distributes regulatory documents.
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.
Develops, assembles and reviews clinical trial documents.
Develop new and review completed internal research proposals, abstract submissions, poster presentations and manuscript drafts.
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.
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.
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.
Reviews and recommends changes to clinical trial documents.
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.
Reviews and maintains trial related documents and operational procedures.
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 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.
Collects, distributes and submits 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.
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,
Develops training plans and trains staff on the proper techniques for protocol submission.
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.
Travel Requirements
0 - 10%
Salary Grade
Job Requirements
Masters degree in Health Medical Professions, Nursing, Biology, Multi-disciplinary or General Science
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.
Clinical research related certifications preferred.
Cape Fox Corporation, its subsidiaries and affiliates provide equal employment opportunities to all persons and prohibit employment decisions on the basis of race, religion, color, creed, national origin, sex, age, disability, political affiliation, protected veteran status, or sexual orientation. Cape Fox Corporation, its subsidiaries and affiliates offer preference to Cape Fox Corporation shareholders, descendants and other Native Americans pursuant to Public Law 100-241.
Category
Location
#J-18808-Ljbffr