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Study coordinator Jobs in Gladenbach

Zuletzt aktualisiert: vor 4 Tagen
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 11 Tagen
Director, Clinical Portfolio Execution

Director, Clinical Portfolio Execution

CSLEMEA, DE, Marburg, CSL Behring
Vollzeit
CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives.Millions of people around the world are living with rare and serious medical conditions.CSL Behring is co...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
  • Gesponsert
Duales Studium Wirtschaftsingenieurwesen Management (B.Eng.) am virtuellen Campus

Duales Studium Wirtschaftsingenieurwesen Management (B.Eng.) am virtuellen Campus

IU Internationale HochschuleMarburg, Germany
IU Duales Studium : Maximal praxisnah.Lehrveranstaltungen an zwei Tagen pro Woche am virtuellen Campus.Vertiefe anschließend Dein Wissen mithilfe unserer interaktiven Lernmaterialien.Deine Praxispha...Mehr anzeigenZuletzt aktualisiert: vor 4 Tagen
  • Gesponsert
Duales Studium Wirtschaftsingenieurwesen Industrie 4.0 (B.Eng.) am virtuellen Campus

Duales Studium Wirtschaftsingenieurwesen Industrie 4.0 (B.Eng.) am virtuellen Campus

IU Duales StudiumMarburg
Campus genau das Richtige für Dich!.Januar, April, Juli oder im Oktober.Du wirst in unserem Studienmodell des.Lernmaterialien sowie unsere Lern-KI nutzen. Vertiefe anschließend Dein Wissen mithilfe ...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
  • Gesponsert
Duales Studium Soziale Arbeit (B.A.) am virtuellen Campus - Social Services Schwieder

Duales Studium Soziale Arbeit (B.A.) am virtuellen Campus - Social Services Schwieder

IU Group N.V.Wetter (Hessen), Hessen, DE
Du möchtest im Bereich Soziale Arbeit durchstarten? Beginne Dein duales Studium beim passenden Praxispartner.Erlebe unser duales myStudium mit virtuellen Lehrveranstaltungen an zwei Tagen pro Woche...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Projektkoordinator (m / w / d)

Projektkoordinator (m / w / d)

RandstadLollar, Hessen
Befristet
Ihre Karriere ist kein Zufall! Profitieren Sie von unserem einzigartigen Netzwerk : Unser Tochterunternehmen GULP Solution Services sucht aktuell im Raum Lollar einen Project Coordinator.Sie sind In...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
Director RWD Scientist

Director RWD Scientist

SEC Life SciencesHessen
Unbefristet
Are you ready to shape the future of healthcare through cutting-edge data analytics? We are seeking a dynamic.Director, Real World Data (RWD) Scientist. This is an exciting opportunity to leverage y...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
CTS Packaging & Labelling Specialist (all gender)

CTS Packaging & Labelling Specialist (all gender)

OSB AGMarburg
IMP) for global clinical programs, including Investigator Initiated Trials (IITs).IMP label text translations and providing consultancy to CTS study teams on packaging. SAP-based packaging orders an...Mehr anzeigenZuletzt aktualisiert: vor über 30 Tagen
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Sr. Clinical Research Associate

Sr. Clinical Research Associate

AvaniaHesse, DE
Vor 11 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