Clinical Trial Associate Jobs

Description

Key Responsibilities

• Participate in project management meetings and provide an overview of TMF status, clinical study administration, resources, quality, and workload on a regular basis.
• 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.
• Support the Clinical Operations Manager(s) coordinating project meetings, including scheduling and drafting, distribution, and filing of meeting agendas and minutes.
• Assist in data listing review and clinical study report listing review
• Inform the Clinical Operations Manager/Project Team on any outstanding document(s).
• 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 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.

Additional Skills & Qualifications

Experience & Education

• Strong skills with Microsoft Excel and SharePoint are required.
• Good problem-solving skills, a strong sense of urgency, keen attention to detail, ability to work independently and the ability to effectively manage multiple priorities in an environment under time and resource pressures are required.
• Proficiency with Microsoft Word, Microsoft PowerPoint, Microsoft Outlook, and Adobe Acrobat is required.
• Experience in managing eTMF platforms in an outsourced environment is required, with a minimum of 2 years of experience strongly preferred.
• 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.
• Understanding and working knowledge of regulations and standards applied in clinical areas, medical devices, and/or pharmaceutical products is required.
• Bachelor's degree, or equivalent, in a biomedical, life science, or related field of study is preferred. Associates degree with 5 years of clinical operations experience may be considered.

About Actalent

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.