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
- 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.
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
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.