Susan Naacke

Angestellt, Senior Clinical Research Associate, NAMSA
Essen, Germany

Fähigkeiten und Kenntnisse

Site Management
Onsite and Remote Monitoring
Teamability and strong communication skills
Phase II-IV
Site Selection - Close Out
Training of Junior CRA
EDC
Klinische Studien
MS Office
Englische Sprache
Klinisches Monitoring
Zuverlässigkeit
Teamfähigkeit
Kundenorientierung
Analytisches Denken
Klinische Forschung
CTMS
Soziale Kompetenz
iso 14155:2020
MPG
MPKPV
MPSV
ICH-GCP
eCRF
eTMF

Werdegang

Berufserfahrung von Susan Naacke

  • Current 4 years and 6 months, since Jan 2022

    Senior Clinical Research Associate

    NAMSA

    Medical Device Studies, cardiovascular and endocrinology therapeutic areas. Study Site Management all visits, onsite and remotely. D-A-CH region. Maintain trial overview, report to study management. Serving as primary point of contact, effective liaison with internal and external team members. Assist with management and maintenance clinical trial material and study devices. Collection, review and tracking of essential documents, eTMF maintenance. Several eCRFs, Medidata Rave. eCRF UAT

  • 5 years, Jan 2018 - Dec 2022

    Senior CRA

    Clinlogix Europe GmbH

    Medical Device Studies, cardiovascular and endocrinology therapeutic areas. Study Site Management all visits, onsite and remotely. D-A-CH region. Maintain trial overview, report to study management. Serving as primary point of contact, effective liaison with internal and external team members. Assist with management and maintenance clinical trial material and study devices. Collection, review and tracking of essential documents, eTMF maintenance. Several eCRFs, Medidata Rave. eCRF UAT, training/teaching

  • 4 months, Sep 2017 - Dec 2017

    Senior Clinical Research Associate

    IQVIA - Quintiles and IMS Health are now IQVIA

    Senior Clinical Research Associate, study site management all visits, trial overview, clinical studies phase II - IV, onsite and remotely TMF maintenance. Maintenance of IMP and clinical trial material. Acting as effective liaison with study team members.

  • 11 years and 1 month, Aug 2006 - Aug 2017

    Senior Clinical Research Associate

    Therametrics

    Senior Clinical Research Associate, study site management all visits, trial overview, clinical studies phase II - IV and NIS, onsite and remotely, mentoring of Junior CRA, Wide range of indications, e.g. Endocrinology, Gastroenterology, Dermatology, Urology, Pulmonary diseases, Neurology, Oncology, studies with children and Alzheimer's disease. TMF maintenance. Maintenance of IMP and clinical trial material. Acting as effective liaison with study team members.

  • 2 years, Aug 2004 - Jul 2006

    Clinical Research Associate

    Therametrics

    Clinical Research Associate, Monitoring of clinical studies phase II - IV and non-interventional, onsite and remotely, from site evaluation to COV

  • 1 year and 7 months, Jan 2003 - Jul 2004

    Junior Clinical Research Associate

    Therametrics

    Monitoring Clinical Trials

Ausbildung von Susan Naacke

  • 7 years and 8 months, Nov 1993 - Jun 2001

    Biologie

    Universität zu Köln

    Zoologie, Botanik, Organische Chemie

Sprachen

  • German

    C2 (Verhandlungssicher / Muttersprachlich)

  • English

    C1 (Fließend)

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