Clinical Trial Assistant
Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there's no better place to grow your career than Advanced Clinical.
The Clinical Trial Assistant (CTA) will support the clinical project teams in the following areas: accurately update and maintain clinical systems within project timelines; prepare, handle, distribute, file, and archive clinical documentation and reports including maintaining clinical trial management systems (CTMS);; prepare, handle, and distribute clinical trial supplies (other than test article); and maintain relevant tracking information;. The CTA may act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation. The CTA may contact clinical trial sites via phone, fax, and email as needed. The CTA will perform administrative tasks to support team members with clinical trial execution as needed. This role functions as in-house support staff member for clinical trials.
- Follow applicable Standard Operation Procedures (SOPs)
- Assist with the creation and maintenance of documentation for given clinical studies including but not limited to: training materials, operations/regulatory/pharmacy/other binders, monitoring plans, presentations, reports, and journal articles.
- Submit applicable documents to the Trial Master File (TMF). Under the supervision of the PM or designee. Under the supervision of the PM, assist with maintenance of tracking tools of clinical studies. Produces reports from tracking systems as required.
- Responsible for accurate distribution of all clinical trial related materials (other than test article) to clinical trial sites or clinical team/CRA members.
- Requests SharePoint (or other Enterprise-level system) user access and manages project level file structure within the system.
- Manages and maintains user assignments for electronic data capture (EDC) and/or interactive web-response systems (IWRS) or interactive voice-response systems (IVRS) as per project specifications.
- Assist CRA(s) in preparation for clinical trial site monitoring visits.
- May interact with external contacts to assist in management of vendors.
- Assist in the creation of study materials, presentations, and other materials based on existing templates.
- Assist with the preparation of agenda, meeting minutes, and action item tracking.
- High school diploma/certificate or educational equivalent; BS/BA preferred;
- Strong computer and software skills including proficiency in use of Microsoft Word, Excel, Outlook, Project, PowerPoint and Adobe Acrobat.
What's in it for you? Advanced Group offers competitive compensation, comprehensive benefits packages, and a flexible work environment designed to help our team members and their families stay healthy, meet their financial goals, and generally thrive in and beyond work. Visit the links below to discover all that Advanced Group has to offer:
- Our Culture: https://careers.advancedgroup.com/embrace-our-culture
- Career Development Opportunities: https://careers.advancedgroup.com/realize-your-potential
- Community Programs: https://careers.advancedgroup.com/unleash-your-passion
For a complete list of all of our job openings, please visit Advanced Group's career site here .
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
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