Please refer to JobSuchmaschine in your application
Ref. Nr. 2013 Clinical Research Associate
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
(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
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
Bereich/Funktion: - Clinical Research Associate
Reisetätigkeit: 60% - 80%