Clinical Trial Assistant

Description:Key Responsibilities

• Assist the Clinical Operations Manager(s)/Project Team to prepare and maintain eTMF, ensuring tracking of essential study documents and periodic review to assure accuracy and completeness.
• Inform the Clinical Operations Manager/Project Team on any outstanding document(s).
• Assist in the tracking and oversight of all start-up activities (site and country study submissions, clinical trackers and essential documents status) and oversight of third party vendors.
• Participate in project management meetings and provide an overview of TMF status, clinical study administration, resources, quality, and workload on a regular basis.
• Support the Clinical Operations Manager(s) coordinating project meetings, including scheduling and drafting, distribution, and filing of meeting agendas and minutes.
• Communicate effectively with clinical study administration vendors (Functional Service providers etc.).
• Assist in coordination of Investigator and Vendor payments, tracking of payments and accruals, if applicable.
• Assist in data listing review and clinical study report listing review

Additional Skills & Qualifications:Experience & Education

• Bachelor's degree, or equivalent, in a biomedical, life science, or related field of study is preferred.
• Open to candidates who want to learn and grow in clinical trials
• Familiarity with GCPs, ICH guidelines, and FDA regulations is preferred. Familiarity with EMA/CHMP regulations and guidelines and other international regulatory requirements is a plus.
• Proficiency with Microsoft Word, Microsoft PowerPoint, Microsoft Outlook, and Adobe Acrobat is required.
• Strong skills with Microsoft Excel and SharePoint are required.

About ActalentActalent 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 for other accommodation options.