职位描述：
JOB PURPOSE:
Sets up, monitors and reports on clinical trials in conformity with ICH / GCP, WWCD SOPs and local /regional regulation.
KEY ACCOUNTABILITIES:
1.Participates in the creation of clinical trial documents in collaboration with the clinical project leader.
2.Identifies and selects investigators in collaboration with the clinical project leader
3.Prepares / collects all documents needed prior to study initiation.
4.Performs / participates in study set up visits in the investigational centres (hospitals, CROs…) and organises / participates in study initiation meetings in which are provided scientific and technical knowledge concerning the study procedures and its organisation.
5.Ensures monitoring follow up:
Relations and rendez-vous with the investigational centres.
Follow up of trial progress and quality control of data (source document check).
Documentation of protocol violations, adverse events and premature treatment cessation.
Identification and resolution of all problems: logistical, methodological, human technical, which occur during a study.
Management of the local trial files
Management of the investigator’s trial file
Management of trial related logistics
Detection and reporting of deviations, finding and implementing corrective measures
6Provides timely written documentation of all visits / contacts in appropriate reports.
7.Performs post study monitoring visits to close investigational centres.
8.Manages documents on a local level:
CRFs and special forms
DRFs
Data entry into the monitoring tool.
Mail, contact reports, monthly activity reports
9.Prepares, organises and participates in investigator’s meetings
10.Participates in internal & external education and training
11.Prepares and follows up investigational centres and system audits (QA)
12.Organises the trial filing and archiving
JOB-HOLDER ENTRY REQUIREMENTS:
Education:
Minimum bachelor degree in clinical medicine or pharmacy
Experience & knowledge:
Previous experience in monitoring clinical trails is required
Core competencies:
Good command of English (written and spoken)
Knowledge of PC (WORD, EXCEL, POWERPOINT)
Interpersonal communication skill
Team player
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