Medic dermatolog - Studii clinice
Adaugat: 4 zile în urmă
PuntoUP
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Key Responsibilities
- Coordinates and leads the technical conducting for clinical study in accordance with the main Investigator's instructions;
- Establishes the inclusion and exclusion criteria necessary for conducting the clinical study and communicates them to the study documentation and/or recruitment department personnel at the Investigator's request;
- Participates in the evaluation of the study request/protocol;
- Provides the necessary information about the study project to the Internal Ethics Committee, External Ethics Committee, or IRB (Institutional Review Board) for evaluation;
- Prepares/verifies/approves/complies with/applies/transmits to the Sponsor the protocol and/or its amendments as a support for documentation department;
- Approves and signs the study report, ICF (informed consent form), CRF (Case Report Form) and all component documents of the ISF (investigational study file) according to current procedures;
- Protects the rights, safety, and comfort of study participants;
- Includes subjects in the study by verifying clinical inclusion criteria,
- Ensures the follow-up of the subjects involved in an adverse event as long as necessary;
- Ensures that during the clinical study, the study team under their supervision complies with the assigned responsibilities;
- Documents and informs the Internal Ethics Committee, External Ethics Committee, or IRB (Institutional Review Board) of any protocol deviations, adverse events, and/or significant adverse events;
- Records and secures source data in both electronic and paper formats;
- Verifies and re-verifies source data recorded by technical department employees in source documents;
- Makes corrections and/or implements necessary corrective actions and/or requests corrections in source documents within the clinical study process;
- Notifies the Sponsor or their designated persons about adverse events according to the study protocol and current procedures at the Investigator's request;
- Clinically examines each potential subject during the subject recruitment process; creating a brief history regarding personal physiological, pathological, hereditary, and treatment history, and a questionnaire regarding cosmetic habits;
- Verifies the health status of each subject in accordance with the notion of "healthy subject" as defined in the company's "General Conditions for Conducting Human Tests";
Benefits
- International working environment
- Opportunity to collaborate with very known brands
- Private medical insurance
- Meal vouchers
- Performance bonuses
- Transportation subscription / support
- Clear procedures, training, and a stable, professional medical framework
Sfaturi de siguranta
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