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Clinical Trial Assistant (CTA)
SanaClis s.r.o.
Place of work
Bratislava
Bratislava
Contract type
full-time
full-time
Start date
to be agreed
to be agreed
Wage (gross)
1 200 EUR/monthbasic gross; the salary will be agreed based on qualification, experience and skills of an applicant
1 200 EUR/monthbasic gross; the salary will be agreed based on qualification, experience and skills of an applicant
Information about the position
Job description, responsibilities and duties
We are looking for a CTA with good communication, organizing and time management skills;
You will support the Clinical Operations team with ongoing conduct of clinical studies. Including:
Provide general administrative support to the Clinical Operations Department and assistance to Project Director(s)/Manager(s) and CRAs.
Assist CRA/PM in study-related tasks (organization of travel, filing, copying, translation from/into English, supplies planning and local purchasing, archiving, etc.) as requested by CRA/PM.
Assist CRAs in preparation of clinical trial application (CTA) and its submission to ethics committees (EC) and national regulatory authorities (RA).
Help in preparation of ISFs and other study related files.
Update tracking forms and other relevant documents as requested by CRA/PM.
Assist in quality control checks of clinical trial documentation (e.g. TMF, ISF, CTA, etc.) including preparation for internal/external audits, final reconciliation and archival.
Communicate with investigators, authorities, sponsor (phone, e-mail, face to face) on behalf of CRA/PM in respect to all study related issues delegated to CTA by CRA/PM. Inform CRA/PM about the results correspondingly.
You will support the Clinical Operations team with ongoing conduct of clinical studies. Including:
Provide general administrative support to the Clinical Operations Department and assistance to Project Director(s)/Manager(s) and CRAs.
Assist CRA/PM in study-related tasks (organization of travel, filing, copying, translation from/into English, supplies planning and local purchasing, archiving, etc.) as requested by CRA/PM.
Assist CRAs in preparation of clinical trial application (CTA) and its submission to ethics committees (EC) and national regulatory authorities (RA).
Help in preparation of ISFs and other study related files.
Update tracking forms and other relevant documents as requested by CRA/PM.
Assist in quality control checks of clinical trial documentation (e.g. TMF, ISF, CTA, etc.) including preparation for internal/external audits, final reconciliation and archival.
Communicate with investigators, authorities, sponsor (phone, e-mail, face to face) on behalf of CRA/PM in respect to all study related issues delegated to CTA by CRA/PM. Inform CRA/PM about the results correspondingly.
Employee perks, benefits
We are an equal opportunities employer, in terms of gender and age. We create family friendly environment offering flexible working time, babysitting, home based work. We care about work-life balance of our employees.
Other employee benefits will be specified during job interview
Other employee benefits will be specified during job interview
Information about the selection process
A successful candidate must have:
Knowledge of clinical research processes and medical terminology.
Good knowledge of ICH GCP, national Regulatory requirements.
Previous experience in CTA position or familiarity with clinical trials is a benefit.
Good knowledge of English language is a must; knowledge of other languages (preferably HU) is an advantage.
Knowledge of clinical research processes and medical terminology.
Good knowledge of ICH GCP, national Regulatory requirements.
Previous experience in CTA position or familiarity with clinical trials is a benefit.
Good knowledge of English language is a must; knowledge of other languages (preferably HU) is an advantage.
Requirements for the employee
Candidates with education suit the position
University education (Bachelor's degree)
University education (Master's degree)
Postgraduate (Doctorate)
University education (Master's degree)
Postgraduate (Doctorate)
Educational Specialization
preferred qualification in nursing, life sciences or medical sciences
Language skills
English - Upper intermediate (B2) and Slovak - Proficiency (C2)
Other knowledge
Microsoft Outlook - Advanced
Microsoft Excel - Advanced
Microsoft PowerPoint - Advanced
Microsoft Word - Advanced
Microsoft Excel - Advanced
Microsoft PowerPoint - Advanced
Microsoft Word - Advanced
Driving licence
B
Personality requirements and skills
We expect you to be well organized, able to prioritize and overview the whole picture as well as focus on details.
You must have strong written and verbal communication skills be confident in communication and be able to work remotely in international teams.
Having good social and cooperation skills and being great support to others is crucial for succeeding in this career.
You must have strong written and verbal communication skills be confident in communication and be able to work remotely in international teams.
Having good social and cooperation skills and being great support to others is crucial for succeeding in this career.
Advertiser
Brief description of the company
We provide our customers with a comprehensive range of worldwide & end-to-end solutions for clinical trials throughout the entire life cycle of the study. Adapting to the needs of the sponsor, SanaClis is able to work both as a full and functional service provider.
*SanaClis is an equal opportunity and inclusive employer
*SanaClis is an equal opportunity and inclusive employer
Number of employees
200-249 employees
ID: 3740490
Posting date: 19.11.2020
2020-11-19
location: Bratislava Position: Clinical Research Associate Company: SanaClis s.r.o.
Basic salary component (gross): 1 200 EUR/month