Our company is a leader in clinical research services and is committed to commercializing novel treatments. Being a part of one of the top worldwide contract research organizations (CROs), we provide unparalleled clinical and scientific knowledge. Our group is essential to the creation of medications that can save lives and solve some of the most important health issues facing the globe. We support each phase of the drug development process with a dedication to quality and excellence, having a real effect on world health.
Responsibilities in Job
You will be a vital member of our regulatory team as an assistant to regulatory affairs. Your primary duties will consist of:
- delivering administrative support, including scheduling meetings, organizing travel, and managing expenses.
- overseeing the archiving and retrieval of documents and making sure that all company development and regulatory documentation is current.
- supporting the administration and updating of Work Process Documents (WPDs) and Standard Operating Procedures (SOPs).
- supporting the upkeep and updating of use tools and departmental websites.
- helping to preserve records and regulatory filings in order to guarantee adherence to regulations and readiness for audits.
In the role of Clinical Trial Coordinator II, your responsibilities will expand to:
- Supporting the Project Team with administrative and technical tasks, ensuring timely and accurate document processing.
- Assisting in the development and review of site activation plans and site tiering processes.
- Ensuring compliance with SOPs, ICH GCP guidelines, and regulatory requirements.
- Collaborating with internal teams to support site start-up activities and regulatory submissions.
Qualifications
The accompanying credentials are necessary for the position of Regulatory Affairs Assistant:
- a high school graduation or a comparable degree from another institution or profession.
- two or more years of equivalent experience, ideally gained in the CRO or pharmaceutical sectors.
The following are preferred qualifications for the role of Clinical Trial Coordinator II:
- a life sciences bachelor’s degree.
- two to five years of experience working as a clinical trial coordinator (CTC) or clinical research coordinator (CRC).
- understanding of regulatory compliance, ICH GCP principles, and eTMF.
Skills
The following abilities are what the best applicants for these positions should have:
- Organizational Skills: Capacity to effectively oversee several projects and guarantee that all project deadlines are fulfilled.
- A sharp eye for precision in data analysis and documentation is known as attention to detail.
- Communication Skills: Excellent written and spoken communication skills, as well as fluency in pertinent regional languages and English.
- Technical Proficiency: Proficiency with clinical trial database systems and Microsoft Office.
- Team Collaboration: Possessing excellent interpersonal skills and the capacity to work both alone and collaboratively.
Additional competencies needed for the Clinical Trial Coordinator II position include:
- Problem-Solving: The capacity to recognize hazards, report them, and take the initiative to fix problems on the site.
- Proficiency in Instruction: Handled new hire onboarding and system and process orientation.
How to Apply
We invite you to apply if you satisfy the requirements and are driven to change the field of clinical research. Please visit our careers page to apply for the positions of Clinical Trial Coordinator II and Regulatory Affairs Assistant. You must send your resume and a cover letter describing your relevant expertise and why you would be a wonderful addition to our team. Join us in advancing healthcare and providing patients around the world with cutting-edge treatments.
Application Link For Regulatory Affairs
Application Link For Clinical Trial Coord
