Document Review Specialist II, US Remote Based

Fortrea • Durham, CA

1d • $65,000 - $73,000 • Remote

About The Position

Joining Fortrea as a Document Review Specialist II today and you will have a rewarding career, a chance to work in an energetic & team-oriented workplace and exposure within a world-leading team. The Document Review Specialist II role is responsible for reviewing country and global project documents following the required guidelines. Document review Specialist II is responsible for drafting global project plans and supporting mentoring of lower-level staff This is full time, remote exempt opportunity based in US. Your responsibilities Review Initial/Amended Investigator Packages to assure compliance with regulatory requirements before granting regulatory green light to a site to start enrolling patients into the clinical trial. Review Core/Country/Site Informed Consent Form to assure compliance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines. Review Patient Recruiting materials (Advertisements) to assure compliance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines. Review Core Protocol for thoroughness and completeness and to assure compliance with Good Clinical Practice (GCP) guidelines. File Informed Consent Form, Patient Recruiting materials, and Investigator Package approval documentation in TMF and eTMF. Draft Investigator Package Plans that document the required quality of documents included in Investigator Packages following the available SOP with manager oversight Act as Document Review mentor on Informed Consent Form and Investigator Package as per mentoring plan for lower-level staff And all other duties as needed or assigned

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).
• Fluent in English, both written and verbal.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Strong knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines.
• 3 years’ work experience in clinical research
• Computer proficiency in MS Office (Word, Excel, PowerPoint, Access, Outlook e-mail and internet services)
• Excellent oral and written communication and presentation skills.
• Excellent proof-reading skills
• Good time managementskills with ability to consistently prioritize workload to accommodate multiple tasks and projects
• Ability to work independently within a flexible team environment
• Work is performed in an office environment with exposure to electrical office equipment.
• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.

Nice To Haves

• Training Lower-level staff (Preferred)

Responsibilities

• Review Initial/Amended Investigator Packages to assure compliance with regulatory requirements before granting regulatory green light to a site to start enrolling patients into the clinical trial.
• Review Core/Country/Site Informed Consent Form to assure compliance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines.
• Review Patient Recruiting materials (Advertisements) to assure compliance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines.
• Review Core Protocol for thoroughness and completeness and to assure compliance with Good Clinical Practice (GCP) guidelines.
• File Informed Consent Form, Patient Recruiting materials, and Investigator Package approval documentation in TMF and eTMF.
• Draft Investigator Package Plans that document the required quality of documents included in Investigator Packages following the available SOP with manager oversight
• Act as Document Review mentor on Informed Consent Form and Investigator Package as per mentoring plan for lower-level staff
• And all other duties as needed or assigned

Benefits

• Medical
• Dental
• Vision
• Life
• STD/LTD
• 401(K)
• Flexible time off (FTO)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level