Responsibilities

CVBF is looking for an experienced Regulatory Officer with strong relationship skills and the ability to work independently whilst establishing a high-trust environment with the CVBF Regulatory Team and its partners.

Successful candidate will be able to independently manage the ethical-regulatory processes required for conducting clinical studies (interventional, observational, on drug, ATMP or medical device).

Key responsibilities include:

• Registration and update of the study in recognised international registries (e.g., clinicaltrial.gov, EudraCT)
• Preparation of a master submission package and its adaptation to national/local requirements
• Management of the study authorization process from submission to final approval
• Negotiation of contract with site(s)
• Preparation and management of substantial amendments
• Notification of the end of the study

Expected starting date: September 2022

Qualifications

Successful candidate will have:

• University degree in a science related field or certified health care professional or equivalent experience
• At least 3 years of prior experience conducting ethical-regulatory regulatory submissions
• In-depth working knowledge of ICH-GCP guidelines as well as local and international regulatory requirements
• Fluency in English and local language (written and spoken)

How to apply

Interested candidates are invited to send their updated CV, together with a cover letter, specifying the job offer reference, the current position, salary, and notice period to [email protected].

Responsibilities

CVBF is looking for two experienced Clinical Research Associates to conduct oversight and monitoring activities for profit and no-profit clinical trials.

Expected starting date: September 2022

The successful candidate will be working on both pharmacological and non-pharmacological studies.

Confident candidates with strong site management skills and the ability to work independently whilst establishing a high-trust environment with the Clinical Operations team and the clinical sites’ staff. He/she will constantly work as an integral part of the CVBF monitoring-service study team, remotely and with occasional meetings. The Clinical Research Associate will be responsible for the successful management of investigator sites throughout the entire trial process.

Key responsibilities include:

• Planning and conducting various site visits (site qualification and initiation, monitoring at sites and remote, close-out) in accordance with the clinical monitoring plan
• Developing effective collaboration with investigator site staff to achieve the planned key clinical metrics
• Ensuring the proper storage and accountability of clinical supplies and following-up of drug safety issues
• Ensuring integrity of clinical data by sufficiently maintaining site tracking records and working in compliance with relevant guidelines

Qualifications

Successful candidate will have:

• University degree in a science related field or certified health care professional or equivalent experience
• At least 2 years of prior experience conducting monitoring visits, including site management, from either a pharmaceutical company or a CRO/SMO environment
• Experience in Oncology and Medical Devices
• In-depth working knowledge of ICH-GCP guidelines as well as local and international regulatory requirements
• Fluency in English and local language (spoken and written)

How to apply

Interested candidates are invited to submit their updated CV, together with the completed CRA assessment form, and a cover letter, specifying the job offer reference, the current position, salary, and notice period to [email protected]