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Precision Medicine Group

Moving Science Closer to Health

Regulatory and Start Up Specialist

ComplianceComplianceOtherRemoteJuniorTeam 1,001-5,000Since 2012H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

120 days ago

Salary

$68.7K - $103.1K / year

Seniority

Junior

Bachelor Degree1 yr expExperience acceptedEnglishGCP

Job Description

Regulatory and Start Up Specialist

Precision Medicine Group

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. • Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. • Interaction with CA/EC for study purposes and handling responses to the CA/EC. • Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant. • Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated. • Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. • Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration. • Prepare. review and manage collection of essential documents required for site activation/IMP release. • Customize country/site specific Patient Information Sheet and Informed Consent Forms. • Responsible for/facilitates the translation and co-ordination of translations for documents required for submission. • Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables. • Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country. • When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.

Job Requirements

  • Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience.
  • 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies.
  • Strong communication and organizational skills are essential.
  • Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
  • Fluency in English and for non-English speaking countries the local language of country where position based.

Benefits

  • This role is also eligible for a discretionary annual bonus
  • Health insurance
  • Retirement savings benefits
  • Life insurance
  • Disability benefits
  • Parental leave
  • Paid time off for sick leave and vacation

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