Job Information
Actalent Clinical Documentation Specialist II in Lake Bluff, Illinois
Job Title: Clinical Documentation Specialist IIJob Description
Manage Phase I to IV study activities. This role involves regularly updating and assisting study teams to address issues related to key Trial Master File health indicators, including the completeness, accuracy, and timeliness of all essential documents throughout the lifecycle of assigned clinical trials. Ensures the Trial Master File is always inspection-ready and complies with ICH GCP guidelines.
Responsibilities
Manage Phase I to IV study activities.
Ensure the Trial Master File is always inspection-ready and complies with ICH GCP guidelines.
Regularly update and assist study teams to address issues related to key Trial Master File health indicators.
Ensure the completeness, accuracy, and timeliness of all essential documents throughout the lifecycle of assigned clinical trials.
Essential Skills
Clinical trial management
Trial Master File (TMF) management
Clinical documentation
Knowledge of FDA, ICH, and GCP guidelines
Experience with clinical research and pharmaceutical documentation
Document control and regulatory documents handling
Additional Skills & Qualifications
BS Degree
2+ years of Clinical Research/Clinical Documentation experience with TMF for Phase I-IV studies
Experience with Microsoft PowerPoint and Excel
Familiarity with Document Management Systems
Work Environment
100% Remote
Pay and Benefits
The pay range for this position is $30.00 - $35.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision• Critical Illness, Accident, and Hospital• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available• Life Insurance (Voluntary Life & AD&D for the employee and dependents)• Short and long-term disability• Health Spending Account (HSA)• Transportation benefits• Employee Assistance Program• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully remote position.
Application Deadline
This position is anticipated to close on Mar 19, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.