Clinical Documentation Specialist II

job summary:

• The Clinical Document Management Associate II will ensure the Master File is always inspection-ready and complies with ICH GCP guidelines. This role entails the conduct of rigorous quality checks, ensuring reliable and complete Trial Master File. Collaborate with study teams, providing support to address and resolve issues related to Master File health indicators. Focus on maintaining the completeness, accuracy, and timeliness of all crucial documents throughout the lifecycle of the assigned clinical trials.

location: North Chicago, Illinois
job type: Contract
salary: $35.00 - 40.18 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Actively engages with document owners to ensure that study team members are accountable for their respective sections of the Master file.
• Work collaboratively with document owners and cross-functional teams to resolve document-related issues and harmonize documentation practices. Actively engages with document owners to resolve quality issues during the document filing process.
• Prepares and delivers detailed reports and presentation materials to stakeholders, as well as contributes to and potentially leads internal Business Process Teams and initiatives focused on continuous improvement projects and work streams.
• Offers valuable input and recommendations for Standard Operating Procedures (SOPs), work instructions, and job aids, serving as a subject matter expert and potentially mentoring new hires.
• Prepares and distribute periodic Master File Oversight emails and reports, conduct Master File Oversight Quality Assessments, and initiate actions for functional area reviews.
• Proactively escalates and resolves issues related to Master File completeness, timeliness, and quality, ensuring that any challenges are addressed promptly and efficiently. Maintain a consistent reporting format and frequency.
• Creates and presents reports to study teams, collaborating with functional areas to finalize and archive study Master Files in the electronic Master File system, and supporting audit and inspection preparations to ensure Master File readiness.
• Continuously monitor TMF Health metrics to detect emerging trends, identify potential risks, and implement effective mitigation strategies to ensure document integrity and compliance.
• Offers expert input and recommendations for Standard Operating Procedures (SOPs), work instructions, and job aids, serving as a subject matter expert.
• Provide training and support to new team members, serving as a mentor to guide best practices in document management and conducts QC Checks on document processing of internal and external staff to ensure quality thresholds are being met.

 
qualifications:

• Bachelors degree or international equivalent preferred. Minimum 4 years relevant industry experience in clinical document management or equivalent experience required.
• If there is no bachelor's degree, a total of 6 years professional clinical research relevant work experience.
• Proven analytical and critical thinking skills.
• Proficient knowledge of clinical documentation business procedures.
• Capable of working autonomously with limited oversight.
• Proven oral and written communication skills; ability to facilitate cross-functional team meetings.
• Compliant to clinical documentation processes, identify gaps and propose solutions.
• Collaborative mindset to work effectively across various teams and departments.
• Excellent organizational skills with the ability to manage several projects at the same time.
• Experienced in using Microsoft PowerPoint and Excel.

 
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 View email address on us.fitly.work.




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.