Regulatory & Start Up Specialist, FSP

We are looking for a Regulatory & Start Up Specialist to join our FSP team in a Home Based role!

What You´ll DoPerform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.

• Point of Contact (SPOC) in assigned studies 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.

• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute 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 the progress, the 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 on-going project timeline planning.

• Perform quality control of documents provided by sites.

• May have direct contact with sponsors on specific initiatives.

What Will Help You Succeed

• +2 years clinical research experience submitting clinical procedures to the MoH (ISP).

• Health Sciences degree

• +1 year experience handling the "FEFYM" and “CABA” portal when submitting clinical procedures

• Advanced command of English language.

• Desirable experience in imports/exports that correspond to activities subsequent to the authorization of a clinical protocol in the country.

• Desirable experience in contract negotiations with research sites.

• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.

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