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We are seeking a dedicated and detail-oriented Clinical Trial Assistant to support the management of clinical trials. This role involves direct interaction with clinical research associates, trial managers, site staff, and vendors globally, providing essential support for project-specific tasks and overall trial management.

Responsibilities

+ Interact directly with Clinical Research Associates (CRAs), trial managers, site staff, and vendors to support project-specific tasks and clinical trial management.

+ Support operational leaders, clinical leaders, and clinical trial managers in various tasks.

+ Maintain and manage requests for access to and deactivation of study systems users.

+ Coordinate materials such as PowerPoint presentations, templates, and essential document listings for meetings.

+ Distribute safety alerts and relevant documents as required.

+ Maintain and update study team and vendor contact information.

+ Assist in planning, organizing, and executing study-specific meetings, including writing and distributing agendas and minutes.

+ Participate in reviewing, formatting, and finalizing study-related templates, plans, and manuals.

+ Assist with maintaining clinical trial insurance.

+ Address questions or requests from the Clinical Research Organization and route them to appropriate individuals for resolution.

+ Participate in clinical data review as required.

+ Ensure completeness of documents managed in the Trial Master Files (TMF) and perform ongoing reviews to ensure quality and compliance with SOPs and ICH GCP Guidelines.

+ Route, track, and file clinical documents, and conduct initial and ongoing reviews of site clinical regulatory documentation.

+ Develop and maintain study-related trackers to support clinical operations and individual studies.

+ Analyze or update data associated with trackers.

+ Perform other duties as assigned to support study team leads and operational team leads.

Essential Skills

+ Bachelor’s degree in a relevant field or equivalent work experience.

+ 1-2 years of experience in biotech, pharmaceutical, or clinical trial management.

+ Experience with Trial Master Files (TMF) and quality control.

+ Proficiency in Microsoft Office.

+ Strong understanding of regulatory documents and clinical operations.

+ Experience in clinical data entry and quality assurance.

+ Self-motivated and engaging worker who thrives in a collaborative team setting.

Additional Skills & Qualifications

+ Experience with SimpleTrials or Flex is preferred but not required.

+ Experience in the CNS field is preferred but not required.

+ Up-to-date knowledge of clinical trial regulatory requirements and guidelines (e.g., GCP, ICH, FDA).

Pay and Benefits

The pay range for this position is $40.00 - $43.00/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 Jun 13, 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.

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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.