Regulatory and Start-Up Expert
hace 1 mes
We are seeking a skilled Regulatory & Start Up Specialist to join our cFSP team in a Home Based role.
Location: Argentina & México
Job Summary:
We are looking for a detail-oriented and organized Regulatory & Start Up Specialist to perform site activation activities in accordance with local and international regulations, standard operating procedures, and project requirements.
Responsibilities:
- Act as Point of Contact (SPOC) for assigned studies, ensuring seamless communication with investigative sites, Site Activation Manager (SAM), and Project Management team.
- Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), and quality of designated deliverables and project timelines.
- Perform start-up and site activation activities, distributing completed documents to sites and internal project team members.
- 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 on 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.
- Maintain direct contact with sponsors on specific initiatives.
Requirements:
- Health Sciences degree or related field.
- +3 years of clinical research experience within regulatory area: local regulatory submissions, knowledge of ICF, presentations to ethics committee.
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
- Advanced command of English language.
- Good organizational and time management skills.
- Good communication and interpersonal skills.
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