Regulatory Operations Assistant
Proclinical is currently recruiting for a Regulatory Operations Assistant Opportunity with a global leading pharmaceutical company located in Redwood City, CA. Success candidate will have a Bachelor's degree, 2 years of relevant experience in Clinical Operations and/or R&D.
- Disclosure work performed under the close supervision of more senior staff following detailed instructions with well-defined procedures.
- Register new clinical trials on CTgov & ENCePP.
- Regular updates to protocol records on CTgov & ENCePP.
- Result posting for clinical trials on CTgov, EU-CTR, & ENCePP.
- Perform QC/editing of training manuals, business practices and checklist documents.
- Support continual improvements by evaluating disclosure business process and provide suggestions to enhance compliance and efficiency.
- Attend and participate in routine group meetings. May attend cross-functional meetings under the direction of a more senior staff meeting.
Skills and Requirements:
- 2+ years of relevant experience and a BS degree required.
- Basic understanding of Clinical Development and associated regulations (e.g. FDA, EMA) & best practices (e.g. ICH, GCP).
- Has strong organization skills and attention to detail, along with ability to work on a number of projects with tight timelines is required.
- Clinical R&D experience (e.g. Clinical Operations).
- Has excellent verbal and written communication skills and interpersonal skills.
- Has well developed computer skills including proficiency in Word, Adobe and Excel.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Catherine Nguyen at (+1) 215-531-5643 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.