Regulatory Operations Associate
Proclinical is currently recruiting for a REMOTE Regulatory Operations Associate with a pharmaceutical company.
- Disclosures work is performed under the close supervision of more senior staff following detailed instructions with well-defined procedures.
- Registration of new clinical trials on CTgov & ENCePP
- Regular updates to protocol records on CTgov & ENCePP
- Results posting for clinical trials on CTgov, EU-CTR, & ENCePP
- Performs QC/editing of training manuals, business practices, checklist documents.
- Supports continual improvements by evaluating disclosure business process and providing suggestions to enhance compliance and efficiency.
- Has strong organization skills and attention to detail, along with ability to work on a number of projects with tight timelines is required.
- Attends and participates in routine group meetings. May attend cross-functional meetings under the direction of a more senior staff meeting.
- Has excellent verbal and written communication skills and interpersonal skills.
- Has well developed computer skills including proficiency in Word, Adobe and Excel.
Skills and Requirements:
- 3+ years of relevant experience and a BS degree
- Clinical R&D experience (e.g. Clinical Operations)
- Basic understanding of Clinical Development and associated regulations (e.g. FDA, EMA) & best practices (e.g. ICH, GCP)
If you are having difficulty in applying or if you have any questions, please contact Samantha Reader at 267-983-0134.
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.