2023-08-23 14:48:55

Clinical Research Associate (Baltics)

CVKeskus.ee klient

Job Description

• Working independently and proactively to coordinate all necessary activities required for setting up and monitoring a study, completing accurate study status reports and maintaining study documentation. You will be involved in the submission of protocol, consent documents for ethics/IRB approval and assist in the preparation of regulatory submissions as requested
• Managing sponsor generated queries efficiently and taking responsibility for study cost effectiveness; you will also participate in the preparation and review of study documentation and feasibility studies for new proposals as required.
• Depending on your level of experience, you may assist in training and mentoring less experienced CRA’s and/or manage CRA’s working on international projects

Requirements

• With a University degree in medicine, science, or equivalent; you will have previous monitoring experience in medium sized studies, including study start-up and close-out (for all roles above Entry Level). You should also have strong knowledge of ICH-GCP guidelines and the expertise to review and evaluate medical data
• You will possess excellent written and verbal communication and interpersonal skills enabling you to deal with queries and issues in a timely manner. You should be able to produce accurate work to tight deadlines within a pressurised environment
• You must be available to travel ca 20% of the time (international and domestic -fly and drive) and should possess a valid driving licence
• You will be fluent in both English and Estonian written and spoken.
• You will be performing monitoring activities
• You will be evaluating the quality and integrity of site practices – escalating quality issues as appropriate
• You will be managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion
• You will need to be comfortable collaborating and communicating with a variety of colleagues, investigators and customers.
• You are observant, have responsibility and good computer skills
• You are able to work on your own. You will be supported by manager of the projects

Company offers

We offer you very proffessional, international environment and possibility to work in interesting business field. You will have supportive colleagues and trusting management. We have bonus system and motivation package (incl. compensation for health creation, mobile phone) in place, also possibility to work from home. You will have stable job in international company.

Job location:
The position can be office-based or home-based as new candidate wants.
Time to time the CRA has to come to the office.

Employment Type:
Full-time/ Part-time (0,5 FTE) with possibility to make it full-time

For additional information please contact:
Igne Venceviciute
+37061406228
igne.venceviciute(ät)medfiles.eu