1230 days ago on chemiepharma.ch

Clinical Research Associate

Chemie-Pharma AG

  • Sector
  • Employment type
  • Position

 Please refer to JobSuchmaschine in your application

Clinical Research Associate

Ref. Nr. 2013 Clinical Research Associate

Mandant:

  • One of the world largest and most comprehensive drug development services company.
    Branche: Pharma / Biotech

Stellenbeschreibung:

  • Job Summary

  • Conducts site monitoring of clinical research studies according to the companies Standard
    Operating Procedures, ICH Guidelines and GCP.

  • Assures the implementation of project plans as assigned.

  • May act as Local Project Coordinator. Job Duties and Responsibilities

  • Responsible for all aspects of study site monitoring including routine monitoring and close-out
    of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with
    vendors; and other duties, as assigned.

  • General On-Site Monitoring Responsibilities
    (a) Ensure that the study staff who will conduct the protocol have received the proper
    materials and instructions to safely enter patients into the study.
    (b) Ensure the protection of study patients by verifying that informed consent procedures and
    protocol requirements are adhered to according to the applicable regulatory requirements.
    (c) Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data
    collection tools by careful source document review. Monitor data for missing or implausible
    data.
    (d) Ensure the resources of the Sponsor and the company are spent wisely by performing the
    required monitoring tasks in an efficient manner, according to SOPs and established
    guidelines, including managing travel expenses in an economical fashion according to the
    companies travel policy.
    (e) Prepare accurate and timely trip reports.

  • May undertake feasibility work when requested.

  • Assist with recruitment of potential investigators, preparation of EC submissions, notifications
    to regulatory authorities, translation of study-related documentation, organization of meetings
    and other tasks as instructed by supervisor.

  • May negotiate study budgets with potential investigators and assist the company legal
    department with statements of agreements.

  • Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives
    and follow up of SAEs.

  • Independently perform CRF review; query generation and resolution against established data
    review guidelines on the company or client data management systems as assigned by
    management.

  • May assist with training and development of new employees, e.g. co-monitoring.

  • May co-ordinate designated clinical projects as a Local Project Coordinator (with supervision,
    if applicable), and may act as a local client contact.

  • Perform other duties as assigned by management.

  • Arbeitsregion: Ganze Schweiz

  • Position: Mitarbeiter

  • Bereich/Funktion: - Clinical Research Associate

  • Reisetätigkeit: 60% - 80%

  • Jobsprache: Deutsch

  • Beschäftigungsart: Vollzeit

Gewünschte Fähigkeiten:

  • Sprachkenntnisse

Kontakt:

  • Chemie-Pharma AG
  • Blegistrasse 25
  • 6340 Baar
  • Tel. Zentrale AG ++41 056 648 25 75

E-Mail: info@chemiepharma.ch