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Audit associate • ebsdorfergrund

Zuletzt aktualisiert: vor 21 Stunden
Sr. Clinical Research Associate

Sr. Clinical Research Associate

AvaniaHesse, DE
Vollzeit
Avania is hiring Senior Clinical Research Associates (Sr CRAs) .Avania’s ClinOps Team establishes, maintains and supports clinical trials. as a key member of the team, our Sr CRA pe...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Verkäufer Frischetheke Metzgerei (m / w / d)

Verkäufer Frischetheke Metzgerei (m / w / d)

REWEHomberg (Ohm), DE
Die Frischetheke ist das Herz unserer.Hier teilst du deine Leidenschaft rund um die Themen Fleisch, Wurst, Käse, Frischfisch und Feinkost und berätst unsere Kund : innen mit deinem Fachwissen : .Du übe...Mehr anzeigenZuletzt aktualisiert: vor 21 Stunden
Bereit für Veränderung? Werde IT-Vertriebsmanager & CRM Spezialist (m / w / d) (m / w / d) – Quereinsteiger willkommen!

Bereit für Veränderung? Werde IT-Vertriebsmanager & CRM Spezialist (m / w / d) (m / w / d) – Quereinsteiger willkommen!

Franklin Institute of Applied SciencesMarburg, Hessen, DE
Franklin Institute of Applied Sciences.Wer steckt hinter dem Franklin Institute of Applied Sciences?.Wir erkennen Talente und schaffen für Menschen mit den unterschiedlichsten Hintergründen die Mög...Mehr anzeigenZuletzt aktualisiert: vor 6 Tagen
Associate Finance 1+

Associate Finance 1+

Schollmeyer&SteidlHessen
Diese weltweit agierende Kanzlei sucht Verstärkung für den florierenden Finance-Bereich.In den letzten Jahren erlebte das Team ein gesundes Wachstum und soll nun auf Associate Ebene weiter verstärk...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Ergotherapeutinnen und Ergotherapeuten (w / m / d)

Ergotherapeutinnen und Ergotherapeuten (w / m / d)

Audit LogoHessen, DE
Sie verfügen über eine abgeschlossene Ausbildung als Ergotherapeutin oder Ergotherapeut.Sie verfügen über ein selbständiges und teamorientiertes Arbeiten sowie Freude am Beruf, verbunden mit situat...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Payroll Manager (Switzerland and Germany)

Payroll Manager (Switzerland and Germany)

CSLEMEA, DE, Marburg, CSL Behring
Vollzeit
The Payroll Manager position is responsible for managing a team that processes a large volume, multiple entity and complex payrolls. You are the main contact and SME for the payrolls you support.You...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Internal Audit Manager (w / m / d)

Internal Audit Manager (w / m / d)

Vires ConferreHessen, DE
Termingerechte Durchführung von internen Prüfungsaufträgen und Ad-hoc-Aufgaben.Zusammenarbeit mit externen Prüfungsdienstleistern und internen Stakeholdern. Zusammenarbeit mit hinzugezogenen oder ex...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Junior Consultant Audit (m / w / d)

Junior Consultant Audit (m / w / d)

Genoverband e.V.Hessen
Sie sind auf der Suche nach einer neuen Herausforderung? Sie möchten in Ihrem Arbeitsumfeld gefordert und gefördert werden? Und Sie suchen eine Tätigkeit mit einem tieferen gemeinschaftlichen Sinn?...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Sr. Clinical Research Associate

Sr. Clinical Research Associate

AvaniaHesse, DE
Vor 30+ Tagen
Anstellungsart
  • Vollzeit
Stellenbeschreibung

Avania is hiring Senior Clinical Research Associates (Sr CRAs)

Avania’s ClinOps Team establishes, maintains and supports clinical trials; as a key member of the team, our Sr CRA performs clinical trial oversight for the trials, verifying that the rights and well-being of human subjects are protected, and that reported trial data are accurate, complete, and verifiable (from source documents). Partnering closely with our Trial sites, Avania's Sr CRA ensures that the conduct of the trial follows approved protocols / amendment(s), with ISO14155 or ICH-GCP, and with applicable regulatory requirements.

Our Senior CRA role includes the following key activities -

  • Interact with and guide study investigators and study coordinators in conducting clinical trials in accordance with study protocols. Member of a site Start-up Team for assigned projects.
  • Monitor site’s completion of action items between visits and help prepare for audits and inspections; conduct and write accurate visit reports in accordance with SOPs and GCP (SQV, SIV, IMV, COV)
  • Ensure data entered on the CRFs is timely, accurate and verified. Collaborate with analytical services to obtain clean database, resolve queries and conduct or participate in data reviews (both internally and with sponsor), identifying and communicating trends or erroneous data.
  • Participate in internal TMF reviews, as needed.
  • Develop and maintain trackers, such as visit reports trackers, site trackers, recruitment and enrollment trackers.
  • Review and write informed consent forms. Review of protocols, investigator brochures on compliance with applicable regulations and CRFs in development. Prepare clinical trial agreements and present to site and study sponsor.
  • Review regulatory compliance for study documents and protocols.
  • May act as a Clinical Lead, overseeing clinical trial activities at investigational sites (will require travel to investigational sites).

Candidates who offer a combination of the skills, knowledge and experience listed below are encouraged to apply. With our continued growth we are hiring talent to join us on our journey and grow with us.

Sr CRAs require skills in planning and preparation; sourcing and collecting information; prioritizing tasks and actions; and displaying a proactive attitude to assist in project planning and study execution.

We seek -

  • B.A. / B.S. or equivalent experience in a (para)medical, scientific or health related discipline or related work experience.
  • Minimum 3-7 years of relevant CRA work experience, with extensive cardiology Class III device monitoring experience.
  • Tracker and Start-up experience (with good spreadsheet or similar skills)
  • Ability to understand basic and complex medical details.
  • GCP-ICH-E6, FDA regulations and ISO 14155, 13485 and 9001 knowledge where applicable; knowledge of / ability to learn regulations and guidelines on medical devices and clinical trials.
  • Ability to travel up to 75% domestically and internationally.
  • Experience as a Clinical Lead helpful
  • Strong communicator with excellent presentation skills; able to build rapport with site personnel

    • We offer -

  • The opportunity to work in an innovative, fast-growing and rewarding industry
  • A dynamic and enthusiastic global team that fosters collaboration and the opportunity to work with experts across many specialties
  • Exchange of knowledge and ideas to help employees grow and advance their careers, backed with training and other development opportunities
  • Competitive compensation and benefits package (details shared during the interview process)
  • Some roles offer the opportunities for travel
  • Ask us about our hybrid and fully remote work opportunities

    • We look forward to receiving your application!

    When you need to advance your career, it takes Avania!

    LI-DNI