Job Details
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.