Clinical Documentation Specialist

Position Title: Clinical Documentation Specialist

Work Location: North Chicago, IL 60064 (Hybrid preferred.)

Assignment Duration: 12 months (possible extension-performance based)

Work Arrangement: Hybrid preferred

Position Summary: This role is focused on the Trial Master File (TMF) for clinical studies. The individual will work with document owners and study team members to ensure accountability for their respective sections of the Master File and will work collaboratively with document owners and cross-functional teams to resolve document-related issues.

Key Responsibilities:

* Work with document owners and study team members to ensure accountability for their respective sections of the Master File and work collaboratively with document owners and cross-functional teams to resolve document-related issues.

* Evaluate reporting to ensure information is complete, accurate, and timely for the clinical trial with close attention to detail.

* Participate in quarterly meetings with a wide variety of members, utilizing strong communication skills for those meetings and for activities outside those specific tasks.

* Perform significant work with Excel and PowerPoint, including Excel reporting and PowerPoint presentations.

* Continuously monitor TMF Health metrics to detect trends, identify potential risks, and implement mitigation strategies to ensure document integrity and compliance. * Manage several studies at the same time using excellent organizational skills.

Qualification & Experience:

* TMF background is preferred, and a clinical study/clinical research background is also preferred.

* Ability to actively engage with document owners to ensure study team members are accountable for their respective sections of the Master File.

* Ability to work collaboratively with document owners and cross-functional teams to resolve document-related issues.

* Strong analytical and critical-thinking skills.

* Ability to continuously monitor TMF Health metrics to detect trends, identify potential risks, and implement mitigation strategies to ensure document integrity and compliance.

* Excellent organizational skills with the ability to manage several studies at the same time.

* Strong attention to detail and the ability to evaluate reporting and ensure that information is complete, accurate, and timely for the clinical trial. * Strong communication skills are required because the individual will conduct quarterly meetings with a wide variety of members and will also need to communicate effectively outside those meetings.

* Experience working with PowerPoint and Excel is preferred.

* Being able to filter through reporting proficiently in Excel would be beneficial. The team has internal individuals creating extensive reporting for everyone to use.

* The team currently uses Veeva Vault. If a candidate does not have Veeva Vault experience, eTMF experience is preferred. If the candidate has neither Veeva Vault nor eTMF experience but has additional clinical-trial background, approximately four years of clinical-trial experience is where the Hiring Manager would be comfortable.

* A bachelor's degree is preferred.

* If a candidate does not have a bachelor's degree, the Hiring Manager would like at least six years of experience. This can be six years with a high school education or six years with an associate's degree.

* If a candidate has a bachelor's degree, the qualifications indicate four years of experience, but the Hiring Manager stated that a candidate with a bachelor's degree and four years, or even somewhat less experience, could still be considered if the overall background is sufficient.

* A master's degree is not a requirement, but if a candidate has one, that is considered fantastic.