Clinical Research Associate

OPIS s.r.l.; Desio; In loco; EUR 30.000 - 40.000; Tempo pieno

Descrizione del lavoro

A biotech-focused CRO in Italy is seeking a Clinical Research Associate (CRA) to coordinate and oversee clinical studies, ensuring compliance with protocols and regulations. The ideal candidate should have a degree in a scientific field and up to 12 months of experience as a CRA. Responsibilities include site monitoring, interaction with regulatory teams, and managing study materials. This role offers a competitive salary and professional growth opportunities within a supportive environment.

Servizi

Competitive salary

Career development opportunities

Bonuses and additional benefits

Competenze

• 0-12 months of experience as CRA.
• Able to work independently under the supervision of others.
• Able to interact with personnel of clinical studies and investigations.

Mansioni

• Coordinate and oversee execution of clinical studies.
• Monitor sites to ensure compliance with protocols and regulations.
• Interact with regulatory teams and manage study materials.

Conoscenze

Knowledge of ICH-GCP

Good knowledge of Office Suite

Good knowledge of English language

Formazione

Degree in a scientific field

Descrizione del lavoro

Clinical Research Associate (CRA) is responsible for coordinating and overseeing the execution of clinical studies, mainly observational, and clinical investigations under the supervision by the Project Manager: identify, select, initiate and close-out appropriate investigational sites for clinical studies and clinical investigations. To monitor those sites to ensure that studies are carried out according to the study protocol and in accordance with CRO/Sponsor SOPs/Wis, any applicable regulations and standards and the principles of ICH GCP, as applicable.

Some of what you'll do:

• Maintain patient and Sponsor confidentiality.
• Participate in the feasibility process of new studies/clinical investigations, collect feasibility questionnaire (if applicable) and other documents necessary for the ethical and administrative submission.
• Perform pre-study/selection visits; verify that the Investigator and staff are qualified for the study and have sufficient available time and resources/facilities; verify that the Site is suitable with regard to its structure, instruments and the availability of patients affected by the pathology being studied.
• Perform initiation visits; ensure that the Investigator and staff have adequate training on study protocol and all related procedures, including the Investigational Medicinal Product/Investigational Product/Medical Device and the ICH-GCP, ISO1455 and any other applicable standards.
• Ensure that essential documents are correctly signed and managed.
• Interact with the Regulatory and submission team and support in collecting the documents or information necessary for the ethical and administrative submission.
• Check that the enrolment schedule is in line with the study plan/projections and motivate
• Investigators to achieve the planned recruitment targets.
• Ensure delivery of study materials and products are available prior to study initiation.
• Ongoing management of study materials, including study product(s), as foreseen for the specific study and as applicable (product supply and return, CRFs, laboratory material and samples, study documents, etc.).
• Conduct regular on site and remote monitoring visits in accordance with the Monitoring Plan, the contract, OPIS/Sponsor SOPs/WIs as appropriate.
• Contact Sites to check patient status, resolve queries and deal with various issues.
• Ensure that all the activities are managed in due time and timelines are respected.
• Ensure accuracy and completeness of data entered into OPIS/Sponsor systems and ensure that
• the confidentiality of the patient is respected.
• Perform source data verification according to the Monitoring Plan or other similar documents.
• Verify that Adverse Events and Serious Adverse Events have been reported according to OPIS and/or Sponsor procedures and in adherence to regulatory requirements.
• Escalation of significant or critical issues according to the relevant procedures.
• Manage queries on an ongoing basis and within the timeframes set.

What we're looking for:

• Degree in a scientific field
• 0-12 Months of experience as CRA
• Knowledge of ICH-GCP and ISO14155 and techniques for the monitoring of clinical studies and clinical investigations.
• Obtain requirements as per local regulation (e.g., for CRA working in Italy, of Ministerial Decree 15.11.2011 in order to conduct interventional clinical trials)
• Able to carry out all the activities related to the monitoring of clinical trials/clinical investigations, guaranteeing the security of information
• Good knowledge of Office Suite
• Good knowledge of English language
• Able to work independently under the supervision of the Project Managers and Clinical Operations Managers
• Able to interact with the personnel of clinical studies and clinical investigations

Who we are:

Founded in 1998 in Italy and now operating at an international level, OPIS is a full-service science driven biotech focused CRO providing premium trial management for multi-country clinical trials, including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects.

OPIS added value lies in its highly specialized professionals who can assist their clients using their deep know-how and experience to guarantee a top-quality level of Clinical Trial Management and ability to operate in a wide range of fields (medical writing, scientific and statistical consultancy for trial design, regulatory activities, pharmacovigilance, etc.) always contributing to our clients’ challenging achievements.

What we offer:

We offer a competitive salary with other benefits/bonuses and opportunity to develop your professional career with an expanding and growing company.

Please read the information notice on the processing of personal data in the candidates information section of our company website.