Clinical Research Protocol Navigator

Work 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 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.

Assists researchers with protocol development, assembly and review of clinical trial documents.

Specific Qualifications:

Master’s in nursing or related field

Any of the following certifications will work:

Certifications & Licenses:

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)

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

Data Integrity

Research

ICH/GCP

Strong writing skills with experience writing clinical research protocols.