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Research Support Technician Gw844
hace 2 meses
Offer Description
ACADEMIC DEGREE
Degree + official master/equivalent (Justification must be provided with the application).
FUNCTIONS
Monitor the activities of the clinical research project carried out in the assigned centres as defined by the project manager.
Ensure effective communication between the research team/promoter in the centres assigned to him/her.
Carry out the start-up visit and train the research team in the activities of the project.
Carry out the monitoring in compliance with the Monitoring Plan and manual.
Verify that the protocol and its modifications are complied with.
Ensure compliance with Good Clinical Practice standards, applicable legislation, and Standard Operating Procedures.
Perform the clinical research project closure visit.
Prepare the Monitoring and Review Reports to the project manager/promoter.
Keep the essential project documentation updated and correctly filed in the centres assigned to him/her.
Carry out external monitoring in centres participating in the clinical trials of the platform.
Support the resolution of inconsistencies, deviations, and errors in the data collected from the trial (queries).
Ensure traceability of medication delivered to assigned sites.
Maintain the information required from the assigned sites in the project monitoring tools.
Actively collaborate in the quality assurance of the data, documentation, and processes of the assigned centres.
Support the Project Manager in those activities required for the proper development of the project.
Support the Head of Pharmacovigilance and/or the Project Manager in the follow-up of reported RAGI, AAG, RAG, or AAs.
Perform expedited reporting of suspected unexpected serious adverse reactions (SUSARs) from clinical trials.
Produce periodic safety reports on clinical trials.
Follow-up on any safety issues that may occur with investigational medicinal products or medical devices.
Requirements
Research Field: Medical sciences » Health sciences
Education Level: Master Degree or equivalent
Skills/Qualifications
Specialisation in Clinical Pharmacology
Training in Pharmacovigilance
Certification in Good Clinical Practice
Experience in the monitoring of Clinical Trials.
Experience as Data Manager or Study Coordinator in Clinical Trials.
Languages: English
Others: Availability for external monitoring
Additional Information
Benefits:
ANNUAL GROSS SALARY: 22,351.43 € without prejudice to the basic update established in state legislation for 2024
Selection process:
1. Admission of applications.
2. Competition phase.
3. Interview phase: maximum number of candidates to be interviewed: 4. Minimum score for this phase: 10.
4. Report of the Tribunal.
5. Resolution.
Note: in order for candidates to be considered for recruitment and employment exchange purposes, they must have a total score of at least 30 points.
SELECTION BOARD:
President: María del Mar García Saiz, Principal Investigator.
Member: Francisco Galo Peralta, IDIVAL Management Director.
Member and secretary: Maria José Marín Vidalled, Coordinator of IDIVAL's Technological Services.
Work Location(s)
Company/Institute: IDIVAL
Country: Spain
State/Province: CANTABRIA
City: SANTANDER
Postal Code: 39011
Street: C/ Cardenal Herrera Oria, s/n
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