What are the responsibilities and job description for the REMOTE In-House CRA position at Actalent?
Description:
Responsibilities:
• Provide support to the clinical operations team to assist with the execution, management and maintenance of clinical studies
• Communicate with CROs, specialty vendors and investigational sites
• Assist with tracking study progress and maintaining study status updates (e.g., IRB approvals, regulatory document collection, patient enrollment, SDV status, etc.)
• Coordinate preparation, collection, review and tracking of key clinical study documents (e.g. CDAs, Financial Disclosures, Insurance Certificates)
• Coordinate Clinical Study meetings (including drafting agendas and meeting minutes)
• Track and prepare investigator and vendor budget payments
• Assist with the maintenance and QC of the Trial Master File
• Experience with clinical trials registration (CT.Gov) preferred
Additional Skills & Qualifications:
Qualifications:
• BA/BS degree preferred, but not required if relevant work experience
• Must have a minimum of 4 years of clinical trial experience in the pharmaceutical or biotechnology industry
• Must possess a strong knowledge of clinical trial operations, ICH and GCP Guidelines and other applicable regulatory requirements
• Proficient in Microsoft Office (e.g., Word, Excel, and Outlook)
• Strong organizational, communication and interpersonal skills
• Ability to multi-task is essential
• Successful experience working in a team across multiple functional areas
System experience: Veeva Vault
Experience Level:
Intermediate Level
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.
Salary : $45 - $50