Ga naar hoofdinhoud

RA Officer

Postulez ici

Ellen Claes
Recruiter



Ellen Claes
Recruiter
0499752248


Description de l'emploi

Science Talents is part of House of Talents, an international HR services group specialized in bottleneck professions. You will be working in a no-nonsense environment where team spirit, drive and eagerness to learn are key.

We are very open and communicative go-getters who are keen on results and quality.To further strengthen our growth, we are constantly looking for new colleagues within Project Staffing.Working as a consultant equals working with a fixed contract at Science Talents. You get the chance to work on different projects in your field of expertise and gain new experiences in life sciences, the chemical sector, and the food industry. 

Work is important; however, we also attach great value to a healthy dose of fun@work! Triggered? Let's meet!

During this porject as a Regulatory Coordinator you'll be responsible (primarily or in supporting role) for all activities related to the submissions to Ethics Committee(s) and Regulatory/Competent Authorities. In addition, responsibility includes creating, initiating, coordinating, monitoring and maintaining clinical study site documentation.

SCOPE

Ethics Committee Activities

  • Solicit input from clinical teams on assigned synopses, protocols and Informed Consent Documents (ICDs) where appropriate.
  • Ensure the accuracy of managed ICDs and their translations, as well as related regulatory documents for assigned protocols
  • Responsible for preparing CTA submissions to Ethics Committee(s).
  • Responsible within the Regulatory Team to ensure that studies are conducted scientifically and ethically and in compliance with EMA/FDA/ICH/GCP guidances and regulations/laws.
  • Coordinates with PCRU Pharmacists, RegCMC and Dev Ops colleagues to ensure timely and accurate submission of studies to the Ethics Committee(s).
  • Lead the administrative work related to completion of trials (CSR, ASR, SUSAR, AE, etc.), and ensure communications to EC.
  • Ensure end of study reports and annual reports are provided in time to Ethics Committees.

Regulatory Authorities Activities

  • Responsible for preparing CTA submissions to Competent Authorities.
  • Responsible within the Regulatory Team to ensure that studies are conducted scientifically and ethically and in compliance with EMA/FDA/ICH/GCP guidances and regulations/laws.
  • Coordinates with PCRU Pharmacists, RegCMC and Dev Ops colleagues to ensure timely and accurate submission of studies to the Competent Authorities.
  • Lead the administrative work related to completion of trials (CSR, ASR, SUSAR, AE, etc.), and ensure communications to CA.
  • Ensure end of study reports are provided in time to Regulatory Authorities.

Other Activities

  • Responsible for study-specific tasks such as site registration in CTMS/Oracle Siebel and Shared Investigator.
  • Platform (SIP), QC and filling of study documents in PTMF as well as maintenance and archiving of study files (ISF).
  • Act as an SME for SOP updates and review within the functional line.
  • Responsible for providing oversight on specialized regulatory related PCRU projects.
  • Liaison to the project teams for studies scheduled in the PCRU to provide inputs on regulatory aspects.
  • Responsible for the implementation of new processes and work to proactively resolve issues where appropriate.
  • Develop knowledge of the GDPR and optimize its implementation at the PCRU.
  • Lead PCRU teams in accomplishing business needs and resolving issues.
  • Represent the PCRU on local or global initiatives as a subject matter expert where appropriate.
  • Develop and maintain relationships with schools and universities for training site registration.
  • Give input in PCRU documentation to facilitate positive attitude and trust of participants toward clinical research.
  • Participate in training courses as appropriate, and train Regulatory team members with less experience and expertise.

Profil

EXPERIENCE/OTHERS

  • Bachelor’s degree in management, Life Sciences or equivalent, with relevant experience in Regulatory Affairs.
  • A Master in the above-mentioned domains is preferred.
  • Autonomous but with a strong team spirit
  • Accountable, with very keen sense of initiative and leadership skills
  • Strong organizational skills, multiple projects flexibility and very good resistance to stress or a high workload.
  • Detail oriented, precise in oral and written communication
  • Strong IT skills: advanced use of MS Office tools such as Outlook, Word, Excel, PowerPoint, Teams, OneNote.
  • Min. 5 years of experience in pharma, of which at least some years in a regulatory environment
  • Working knowledge of ICH and GCP guidelines required
  • Strong understanding and knowledge of regulatory aspects of drug development
  • Languages : Fluent in French, Dutch and English (written and spoken)
  • Scientific / Medical Knowledge
  • Understanding of basic clinical pharmacology principles, with ability to review emerging safety and efficacy profile of a drug candidate and recognize potential serious adverse effects.
  • Demonstrated understanding of the complexities and recent developments in exploratory research
  • Participates to the successful study conduct of PCRU studies in accordance with ethical, legal, and moral standards,
  • Good Clinical Practices, Good Laboratory Practices, PCRU management requests, Clinical Development and operations (CD&O) and Global product Development (GPD) goals.


ORGANIZATIONAL RELATIONSHIPS

  • The consultant will report for the project to the Clinical Operations Director
  • Functional relationship to clinic physicians in areas of regulatory and ethical oversight for volunteers/study participants.
  • Matrixed relationship to US and Belgium regulatory teams, study teams, and peers in the PCRU-NH.

Postulez maintenant pour RA Officer

Veuillez inclure vos coordonnées, votre formation et votre expérience afin que nous puissions voir rapidement si vous êtes le bon candidat pour le poste.

Coordonnées de contact

Formation et expérience

Nombre d'années d'expérience*
0499752248