Clinical Research Associate
KBP Biomak
Employer Active
Posted 8 hrs ago
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Nationality
Any Nationality
Gender
Not Mentioned
Vacancy
1 Vacancy
Job Description
Roles & Responsibilities
Main tasks:
- Participation in the creation of the monitoring documents (monitoring guidelines, tracking tools, working documents )
- Participation in the regulatory submissions (Competent Authorities and Ethics Committee)
- On-site visits: selection, initiation, monitoring, and close-out
- Serious Adverse Event (SAE) declaration and follow-up
- Management of study drugs: drug accountability, returns, storage conditions, resupplies requests
- Management of the study material
- Investigators Site files preparation, check and update,
- Trial Master File setup and maintenance,
- Study tracking and follow-up tools update
- Case report forms quality control and handling
- Management of queries,
- Communication with the investigational sites,
- Investigators and hospitals contracts management,
- Management of investigator fees and hospital invoices,
- Participation in investigator s meetingRespect of quality commitments
- Respect for quality commitments
- Participating in the improvement of the Quality System: non-conformities management, review/creation of standard procedures and documents.
Required skills and qualities and expected level:
- Good level of English (spoken and written)Knowledge of GCP and ICH Guidelines
- Knowledge of GCP and ICH Guidelines
- Good command of office software (excel, word, powerpoint)
- Analytical, rigorous and organized
- Good interpersonal skills
- Good oral and written communication
- Ability to summarize.
Desired Candidate Profile
Required skills and qualities and expected level:
- Good level of English (spoken and written)Knowledge of GCP and ICH Guidelines
- Knowledge of GCP and ICH Guidelines
- Good command of office software (excel, word, powerpoint)
- Analytical, rigorous and organized
- Good interpersonal skills
- Good oral and written communication
- Ability to summarize.
Required level of education:
- Scientific diploma 4 years diploma research (DIUFARC, DIUFIEC or other )
Required work experience in this role
- Training course of minimum 6 months as a clinical research associate.
Company Industry
- Pharma
- Biotech
- Clinical Research
Department / Functional Area
- Doctor
- Nurse
- Paramedics
- Hospital Technicians
- Medical Research
Keywords
- Clinical Research Associate
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