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.