Join a leading global pharmaceutical organization as a Clinical Documentation Specialist II in a hybrid role based in North Chicago, IL. In this key 1-year contract position, you will drive Trial Master File (TMF) quality, ensuring clinical trial documentation remains inspection-ready and compliant with ICH GCP guidelines.
location: North Chicago, Illinois
job type: Contract
salary: $35.00 - 40.18 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Collaborate with document owners and cross-functional teams to resolve document quality issues and harmonize filing practices.
- Continuously monitor TMF Health metrics to detect trends, mitigate risks, and maintain document integrity.
- Prepare and present detailed TMF oversight reports and quality assessments to clinical study teams and stakeholders.
- Assist in final archiving of electronic Master Files and actively support audit and inspection readiness efforts.
- Offer expert input on SOPs, work instructions, and job aids while mentoring newer team members on best practices.
qualifications:
- Bachelor's degree with 4+ years of clinical document management experience (or 6+ years of relevant clinical research experience without a degree)
- Proficient knowledge of clinical documentation business procedures and ICH GCP standards
- Strong oral and written communication skills with experience facilitating cross-functional team meetings
- Proficiency with Microsoft Office Suite, specifically Excel and PowerPoint
skills: Good Clinical Practice (GCP), Trial Master File (TMF), Electronic Trial Master File (eTMF), International Council for Harmonization (ICH)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
