Site Activation Specialist (m/f/d)

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Infos sur l'emploi

  • Date de publication :

    20 mars 2024
  • Taux d'activité :

    100%
  • Type de contrat :

    Temporaire
  • Langue :

    anglais (Courant)
  • Lieu de travail :

    Rotkreuz

For our international medical partner, Roche Diagnostics Int Ltd. based in Rotkreuz, we are looking for a qualified and motivated Site Activation Specialist for one year with option for extension.

Tasks

  • Responsible for the effective operations and delivery of site activation deliverables across all regions, within the assigned projects
  • Supports the pre-study site identification/selection process for relevant studies through collection and analysis of site feasibility information
  • Maintain regular communications with investigational sites/CRO to ensure timely completion of the required site activation activities/documentation and resolve or escalate issues in a timely manner
  • Collect, receive and perform the first review of required study-specific site regulatory/essential documents in accordance with applicable SOPs, guidelines, and study timelines and requirements
  • Work with sites to ensure informed consent form meets the required regulatory and company requirements
  • Facilitate the translation of essential documents that may be required in languages other than English for the purposes of submission to and approval from Competent Authorities and/or IRB/EC
  • Coordinate the clinical trial insurance process to ensure timely results and support throughout the conduct of the clinical study
  • Coordinate Investigator Review Board (IRB)/Ethics Committee (EC)/other relevant regulatory submissions in collaboration with sites/study teams
  • Support contract and budget negotiations in partnership with Contracting and Study Teams
  • Ensure Purchase orders and Fair Market Value assessments are completed for timely start-start up
  • Support implementation and use of eTools at the site
  • Collect and maintain relevant country, local, state, and site-level regulatory intelligence for future use
  • Work closely with Study Teams to deliver study start-up tasks
  • Support study instrument placements, Obtain import/export licensure
  • Solve identified issues with appropriate timely escalation to the Study Teams
  • Support internal audit and external inspection activities; contribute to CAPAs as required

Must Haves

  • Bachelor's or Master's (no PhD) degree in chemistry, biology, other life sciences, or a related field, or equivalent combination of education and experience
  • Experience in clinical trial planning, including IRB/Ethics Committee, Competent authority submissions and contracts
  • Knowledge of clinical trial methodologies, medical terminology, ICH/GCP
  • Must be fluent in English, German is a plus
  • Experience in study start-up is required or experience as CRA or within clinical research / trial
  • Understand the quality expectations and emphasis on the right first time, attention to detail
  • Ability to organize tasks, time, and priorities, ability to multitask
  • Required to support multi-national team members, and flexibility in working hours may be needed
  • Ability to participate and work effectively with multiple cross-functional teams
  • Ability to work in an ambiguous environment and great communication skills

Nice to Haves

  • Experience with CRO management is a plus
  • Working knowledge of global and local regulatory requirements (IVDR and other applicable regulations) is a plus
  • Additional European language are a plus

Are you interested? Do not hesitate and submit your complete application documents online today.

We also process applications by post, but will not return them for administrative reasons. We look forward to hearing from you!

Wir wertschätzen Vielfalt und begrüssen daher alle Bewerbungen - unabhängig von Geschlecht, sozialer Herkunft, Religion, Alter und Identität. Zur leichteren Lesbarkeit und besseren Verständlichkeit verwenden wir nur eine Gender-Form. Selbstverständlich sind im jeweiligen Kontext alle Genderformen gleichermassen gemeint.

Kontakt
Renata Santos

Arbeitsort
Rotkreuz

Pensum
100%

Position
Mitarbeiter

Branche
Pharma + Chemie + Life Science

Contact

  • Work Selection

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