Clinical Study ICF Writer - US Remote based

Fortrea•Durham, NC

15d•$90,000 - $110,000•Remote

About The Position

Fortrea is looking for a confident, seasoned Doc Review Senior Specialist who can work independently while collaborating with globally based team members. This individual will provide full and independent review of global project and country regulatory documents. The Doc Review Senior Specialist will respond to CAPA’s and may be responsible for mentoring other lower level staff.

Requirements

University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology). Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Expert knowledge of ICH, FDA, IRB/IEC, and other applicable regulations/guidelines.
5 years' work experience in clinical research

Responsibilities

Develop and/or review initial/amended Core Informed Consent Forms (ICFs)
Review Core/Country/Site Informed Consent Form to assure compliance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines
Review and implementation of relevant study-specific plans that describe the required expectations for assigned tasks.
Support system compliance and system data entry, as applicable.
File required task-related documentation in the Electronic Trial Master File (eTMF).
Liaising and follow-up with local teams, Start-up Project Managers, and Sponsors to assure timely approval of Informed Consent Forms in order to meet submission deadlines.
Act as Document Review mentor for lower-level staff and help train lower-level staff on Document Review processes and expectations
Oversee Local Investigator Package reviewers work for a specific country.
Serve on SOP Review Team(s) as expert in Document Review processes and expectations.
Serve as a Subject Matter Expert for partnership processes on Document Review activities such as Informed Consent Form.
And all other duties as needed or assigned