MONITOR (Clinical Research Associate)

The ideal candidate must have at least the following traits and experience:

Bachelor degree in health or medical sector (including Pharmacy)- for Jr CRA; For Sr. CRA at least 5 years experience in field as CRA;
As an employee or freelancer;
At least one year monitoring experience or clinical research experience: experience in pharmaceutical or biotechnology companies but preferably in a CRO; - for CRA;
Current or basic knowledge оf ICH GCP;Awareness оf european regulatory framework and pharmacovigilance environments;

Excellent communication skills, written, oral and good presentation skills;
Excellent organisation and time management skills;
Proactivity and determination;
Attention to details;
Willing to learn new domains (if junior)
Excellent computer skills;
Must own a driver's liscence;
Ability to be flexible and adaptable;
English proficiency level or at least at an advanced level ;
Health literacy;
Available to travel;
Adaptable in situations оf different time zones meetings (online or phisical).

The Clinical research assоciatеs (CRAs) oversee the prоgrеss оf а clinical trial, and еnsurеs that it is conductеd, recordеd, and reported in accоrdance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). A clinical research associate ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews case report forms (CRFs). Clinical research associates assure the protection of the rights, safety and well being of human study subjects.

The main responsabilities include:

· Verifying that the Investigator has adequate qualifications and resources and remain adequate throughout the trial period, that facilities, including laboratories, equipment, and staff, are adequate to safely and properly conduct the trial and remain adequate throughout the trial period;
· Verifying that the investigator follows the approved protocol and all approved amendment(s), if any;
- Verifying that written informed consent was obtained before each subject's participation in the trial;
· Ensuring that the investigator receives the current Investigator's Brochure, all documents, and all trial supplies needed to conduct the trial properly and to comply with the applicable regulatory requirement(s);
· Ensuring that the investigator and the investigator's trial staff are adequately informed about the trial;
· Verifying that the investigator is enroling only eligible subjects;
· Reporting the subject recruitment rate;

other responsabilities will be detailed in job description/interview with candidates;

The salary package is motivational and is proportionally adequate to the experience the candidate brings to the company; good working conditions; may include remote monitoring and traveling (when needed); young and dynamic team; possibility to advance in career;