Clinical Research Coordinator

Job Title : Research Protocol Navigator

Location : Bethesda MD 20814

Duration : 03 Years to Long Term

Shift : 40 Hours / week (Mon to Fri)

Onsite : Yes

Teleworking Eligible : Yes

This is at Federal Client

Overall Position Summary and Objectives :

• The primary role for this Protocol Navigator (PN) position is to provide clinical research regulatory support through the Clinical Trials Unit (CTU) for the 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.
Min Education :
• Master's
• Master's

Certifications & Licenses Preferred :

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)

Field of Study :

• 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
• Miscellaneous Biology

Software :

• Clinical Trial Management System (CTMS)
• Electronic
• Medical Records System
• Electronic Data Capture System

Skills :

• Liaising with regulatory authorities
• Training clinical trial site staff
• Previous clinical trial work
• Phase I or II experience
• Regulatory compliance
• Protocol development
• Protocol navigation
• Regulatory affairs
• Clinical Research
• IRB submissions
• Clinical
• Trials
• On-site visits
• Data Integrity
• Research
• ICH / GCP Strong writing skills with experience writing clinical research protocols

Statement of Work Details :

• 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 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 Protocol Tracking and Management System.
• Organize quality assurance activities with pertinent regulatory bodies such as FDA, pharmaceuticals and others.
• Assist researchers prepare and communicate with IRB and 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 Clinical Trials Unit CTU and staff on the development and preparation of standard operating procedures SOPs pertaining to protocol navigation and regulatory writing for the 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, and offices involved in communication to integrate and ensure consistency of new revised documents with policies
• Collaborate with clinical research scientists, Principal Investigators, Research Coordinators, Protocol Navigators, Sponsor representatives, CTU staff, and safety, regulatory, and monitoring entities
• Attend in-person meetings located at the 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 by 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 Protocol Tracking and Management System
• Organize quality assurance activities with pertinent regulatory bodies such as audits by FDA, pharmaceuticals and others.
• Prepare researcher communication with IRB and 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.
3 days ago