Clinical Research Associate

• competitive remuneration package.
• dynamic working environment, focused on company’s values.
• the opportunity to work on the some of the most prestigious, ground-breaking and challenging projects.
• real career development opportunities and a life-long career with an innovative, forward-thinking clinical research company.

• Deeply acknowledges and strictly follows SOPs, ICH-GCP guidelines and appropriate local and international legislation. The CRA II is responsible for keeping himself/herself continuously informed with regards to any amendments or updates of the above-mentioned guidelines,laws and procedures.
• As soon as a new clinical trial is delegated to him/her, the CRA II has to study and completely comprehend the protocol and other study related documents, as well as bibliography on the disease under study. The CRA II must be in the position to fully explain the purposes, the set- up and the procedures of the clinical trial to the investigators, train, and is also responsible for training and assisting them in the conduct of clinical trials.
• The CRA II should be specifically trained on the therapeutic area/indication and/or the drug under study, but also on the job itself.
• The CRA II is responsible for translating the study related documents to local language, if required.
• Before study initiation, the CRA II will conduct one or more pre-study visits at the potential investigational sites so as to evaluate their resources and facilities. The CRA II should also discuss the study documents (i.e. protocol and Investigator Brochure) with the investigator so as to confirm the availability of the study population and also to agree upon the investigative team’s responsibilities.
• The CRA II works close with the Head of Regulatory for the submission of the study files to the Independent Ethics Committee and Regulatory Authority as well as the submission to the Institutional Review Board by the investigator so as to ensure submissions are not delayed and approval is granted within appropriate timelines.
• The CRA II prepares, checks and updates the Clinical Trial Files throughout the study and ensures the proper archiving of the study-related documents after the trial’s termination.
• If not otherwise agreed, the CRA II is responsible for ensuring that the centers are supplied with adequate study medication, for verifying that drug accountability is performed correctly, and for ensuring the drug’s safe shipment, storage, dispensing, return and destruction.
• The CRA II is responsible for adequate monitoring of the clinical trial conduct at the investigational sites, i.e. performs monitoring visits at the sites
• The CRA II prepares reports to document all discussions, measures and actions made during a monitoring visit or a telephone contact. He/she also sends summary of these reports to the investigators (follow-up letter). The CRA II is also responsible for reporting to the sponsor any comments made by investigators related to the design of the trial or procedures that may explain difficulties at this site.
• At the beginning of each month, the CRA II prepares a trial status update to formally inform his/her immediate supervisor about the progress of the clinical trial during the previous month.
• In case of an audit or regulatory inspection, the CRA II is responsible for informing and preparing the site and facilitating the procedure. The CRA II in collaboration with the appropriate managers supervises that the corrective actions are performed as soon as possible.
• CRA II can be accompanied by a Junior CRA or a CRA I during monitoring visits for training purposes
• The CRA II has a standard number of administrative responsibilities, which are:
• Accurately complete the timesheet with the time spent on each project
• At the end of each month, the CRA II completes a standard expenses form, which has to be approved by the immediate supervisor.
• Planning of the month, which is made in conjunction with the immediate supervisor and the guidelines of the immediate supervisor.
• Participates in all formal activities of the relevant clinical operations department, including group meetings and training sessions.
• Acts as the main link between the company and the investigator
• Collaborates with the designated team to develop feasibility evaluation questionnaires, contact the investigators to collect feasibility-related information, perform site screening and selection.
• Collaborates with the immediate supervisor to arrange study logistics, resources and planning.
• The CRA II handles the financial issues of the study, including investigator payments and hospital/regulatory fees in collaboration with the immediate supervisor according to the appropriate financial agreements and documents.
• Ensures compliance with applicable quality standards, i.e. SOPs, ICH-GCP and legislation. In case that the CRA II suspects that the conduct of a clinical trial deviates from the approved protocol, ICH-GCP guidelines and/or appropriate legislation, the CRA II has to escalate it immediately as per applicable SOP.
• Manages timely subject enrolment and quality data collection

• life Sciences or related degree
• fluency in written and oral English
• computer literacy
• good communication and organization skills

• at least 1-2 years of experience in monitoring.

Randstad