Clinical Research Associate | New Pharmaceutical Company, Bucharest

Our client is a pharmaceutical company with a global presence and offers an open position “Clinical Research Associate” to join our client’s friendly and supportive work environment and get the best working conditions and a great package of benefits. Be the first one to join and get the opportunity to head and develop their office in Budapest!

In this role, you will be responsible for the following:

* Supporting the Clinical Project Managers in trial feasibility process, start-up, and initiation, monitoring and close-out activities.
* Perform routine site visits with minimal guidance, including pre-study, initiation, interim monitoring and closeout visits.
* Visits to include monitoring of proper informed consent procedures, compliance with protocol, relevant study-specific documentation, GCP ICH Guidelines and applicable regulatory requirements, and assurance of good site performance. This is accomplished by a detailed review of subject records, essential documents, investigational medicinal product disposition and accountability and other relevant study procedures. Ensure that site personnel have received the proper materials and instructions to safely enter subjects into the study.
* Prepare accurate and timely trip reports.
* Manage assigned sites by regular contact with site personnel to ensure site compliance, adequate enrolment and understanding of study requirements.
* Identify deficiencies and/or discrepancies related to source documents and Case Report Forms (CRFs) and work with the investigator and site personnel on resolution. Ensure the integrity of data submitted on CRFs or other data collection tools by careful source document review. Monitor data for missing and implausible data.
* -Independently perform CRF review, query generation and resolution against established data review guidelines or data management systems as applicable.
* -Identify and document in writing and adequately follow up with the site personnel and Client/Sponsor all protocol deviations, regulatory and GCP non-compliances or any other issue involving the safety of the subjects.
* Report to the project team and site personnel any findings noted during site visits. This is accomplished by the completion of accurate visit reports and follow-up letters within the project-specific timelines. Significant issues noted must be reported to the appropriate personnel/ project team immediately.
* Identifying and escalating potential risks and identifying retraining opportunities for site personnel.
* Preparation of corrective and preventive (CAPA) plans for issues identified during monitoring activities and pro-active follow of each, individual CAPA until timely resolution.
* Maintenance and management of the relevant project tracking systems as prescribed in the project plans.
* Undertake feasibility work when requested.
* Recruitment and identification of potential investigators.
* Preparation of documents required for Competent Authority and relevant Ethics Committee submissions and notifications, translation of study-related documents (where applicable), and other tasks as instructed by supervisor.
* With minimal supervision, negotiate study budgets with potential investigators/institutions and assist with the execution of site contracts as applicable.
* Administration of site payments in accordance with relevant project instructions.
* Maintain the study files and ensure that files are up-to-date and accurate.

Requirements:

* Academic degree in Medicine, Pharmacy, Science or equivalent;
* min.4 years of experience as a CRA with a focus on III phase of clinical studies (preferably experience with Rheumatoid arthritis and oncology studies);
* Excellent knowledge of ICH-GCP guidelines and the expertise to review and evaluate medical data;
* Proven fluency in Romanian and English languages;
* Driving licence.

This role is going to be fully remote and will require you to travel domestically and internationally 60% of time.

What you can expect in return?

* Great package of benefits ( you can get more details after sending your CV and planning a phone call with us);
* Amazing international team to learn and grow with;
* Car fuel and mobile expenses coverage.

Apply now! We have a high demand for this position!

You can also reach out to me for more details: a.andreenkova@nonstop-recruitment.com

Non Stop is one of the largest and fastest-growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Luxembourg, Switzerland, Romania, the US and the Czech Republic and we hold labour leasing licences across Switzerland.