Regulatory Specialist for Clinical Research
hace 6 días
We are seeking a highly skilled Regulatory & Start Up Specialist to join our cFSP team in a Home Based role.
Key Responsibilities:
- Perform country-level tasks associated with Site Activation (SA) activities in accordance with local and international regulations, SOPs, project requirements, and contractual guidelines.
- Act as the Point of Contact (SPOC) for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
- Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables, and project timelines.
- Prepare site regulatory documents, reviewing for completeness and accuracy.
- Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project-specific information.
- Review, track, and follow up the progress, approval, and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
- Provide local expertise to SAMs and project team during initial and ongoing project timeline planning.
- Perform quality control of documents provided by sites.
Requirements:
- Health Sciences degree or related field.
- 3 years of clinical research experience within the regulatory area: local regulatory submissions, knowledge of ICF, presentations to ethics committee (COFEPRIS / ANMAT).
- Knowledge and ability to apply GCP / ICH and applicable regulatory guidelines.
- Advanced command of the English language.
- Good organizational and time management skills.
- Good communication and interpersonal skills.
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry.
We believe in pushing the boundaries of human science and data science to make the biggest impact possible to help our customers create a healthier world.
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