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Trial Master File Associate Jobs in Naperville, IL

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Senior Clinical Research Associate

Chicago, IL · Hybrid

$110K - $138K/yr

Act as the primary contactandfacilitateefficientcommunications between the client's clinical trial ... Manage site essential document collection and TMF reconciliation with site files * Support sites ...

Blitt and Gaines, P.C.

Associate Attorney

Naperville, IL · On-site

$75K - $125K/yr

Associate Attorney About Blitt and Gaines, P.C. BG is an industry-leading debt collection law firm ... Proficient in Microsoft Outlook, Word and Excel Collection Master or equivalent case file ...

Blitt and Gaines

Associate Attorney

Naperville, IL · On-site

$75K - $125K/yr

... Master or equivalent case file management system experience preferred Interpersonal Skills: Ability to effectively communicate both verbally and in writing. Ability to work well with a diverse group ...

M&A Law Firm PC

Civil Litigation Attorney

Schaumburg, IL · Hybrid

$150K/yr

Civil Litigation Associate Attorney 3-5+ Years of Experience M&A Law Firm, P.C. | Schaumburg, IL ... Build courtroom expertise through regular motion practice and actual trial opportunities * Master ...

Topel Forman

Senior Tax Associate

Chicago, IL · Hybrid

$84K - $104K/yr

... filings. You will have the opportunity to build a strong foundation in tax while contributing to ... Utilizes trial balance and entity‑level workpaper management software to analyze client ...

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Trial Master File Associate information

What are some common challenges Trial Master File Associates face when managing clinical trial documentation?

Trial Master File Associates often encounter challenges such as maintaining completeness and accuracy of documentation, ensuring timely filing of essential documents, and staying updated with evolving regulatory requirements. Managing large volumes of documents across multiple studies and coordinating with cross-functional teams can also be demanding. Effective organization, attention to detail, and strong communication skills are essential to overcome these challenges and ensure compliance with Good Clinical Practice (GCP) guidelines.

What are the key skills and qualifications needed to thrive as a Trial Master File Associate?

To thrive as a Trial Master File (TMF) Associate, you need a solid understanding of clinical research processes, regulatory requirements, and document management, often supported by a degree in life sciences or a related field. Familiarity with electronic TMF (eTMF) systems and knowledge of industry standards like ICH-GCP are typically required. Strong attention to detail, organizational skills, and effective communication help ensure completeness and accuracy in documentation. These skills are crucial for maintaining compliance, supporting clinical trial integrity, and facilitating successful regulatory inspections.

What is the difference between Trial Master File Associate vs Clinical Trial Coordinator?

AspectTrial Master File AssociateClinical Trial Coordinator
CertificationsMay require GCP or regulatory document management certificationsOften requires GCP training, clinical research certifications
Work EnvironmentFocuses on document management within clinical trialsOversees trial operations, patient coordination, site management
Industry UsageCommonly used in pharmaceutical and biotech companiesUsed across clinical research sites and CROs

The Trial Master File Associate primarily manages and maintains essential trial documentation, ensuring compliance and readiness for audits. In contrast, the Clinical Trial Coordinator oversees the overall conduct of clinical trials, including site management and patient coordination. While both roles require knowledge of GCP and clinical research processes, the Associate focuses on document control, whereas the Coordinator handles broader trial operations.

What is a Trial Master File Associate?

A Trial Master File Associate is a clinical research professional responsible for managing and maintaining the Trial Master File (TMF), which is the collection of essential documents for a clinical trial. Their role ensures that all documentation is complete, accurate, and audit-ready throughout the study. TMF Associates support regulatory compliance by organizing, tracking, and archiving documents, often using electronic systems. They work closely with clinical teams and regulatory authorities to facilitate successful trial conduct and inspections.
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Trial Master File Associate jobs near you

Associate Attorney - Litigation

Kelleher + Holland LLC

Barrington, IL • On-site

Full-time

Re-posted 23 days ago

Job description

Job Type
Full-time
Description
Position Overview:
The Associate Litigation Attorney will play a key role in managing cases from inception to resolution. This position is ideal for an attorney with strong writing, analytical, and courtroom skills who is eager to work on sophisticated litigation matters outside of the personal injury space.
Key Responsibilities:
  • Represent clients in all phases of litigation, including pleadings, discovery, motion practice, hearings, settlement negotiations, arbitration, and trial
  • Conduct legal research, draft memoranda, and prepare motions and other court filings
  • Manage written discovery and take/defend depositions
  • Collaborate with partners and senior attorneys on case strategy and client communications
  • Attend court hearings, status conferences, and mediations
  • Develop and maintain strong relationships with clients and internal teams

Why Join Us:
  • Best Places to Work - 2022,2023,2024 and 2025
  • Supportive team culture and collaborative case work
  • Opportunities for growth and advancement
  • Competitive compensation and benefits package
  • Exposure to a wide variety of litigation matters
  • Dynamic firm environment that values innovation and initiative

Requirements
Qualifications:
  • Juris Doctor (JD) from an accredited law school
  • Active license to practice law in [Illinois or relevant state]; additional bar admissions a plus
  • 2-5 years of civil litigation experience preferred
  • Strong legal writing and oral advocacy skills
  • Detail-oriented with excellent organizational and time management abilities
  • Comfortable managing multiple deadlines and working independently or collaboratively
  • Experience in commercial litigation, real estate litigation, employment law, or related areas is a plus

Apply