Clinical Research Associate (CRA)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.Responsibilities
Maintain patient and Sponsor confidentialityParticipate in the feasibility process of new studies/clinical investigations, collect feasibility questionnaire (if applicable) and other documents necessary for the ethical and administrative submissionPerform 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 studiedPerform 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 standardsEnsure that essential documents are correctly signed and managedInteract with the Regulatory and submission team and support in collecting the documents or information necessary for the ethical and administrative submissionCheck that the enrolment schedule is in line with the study plan/projections and motivate Investigators to achieve the planned recruitment targetsEnsure delivery of study materials and products are available prior to study initiationOngoing 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 appropriateContact Sites to check patient status, resolve queries and deal with various issuesEnsure that all the activities are managed in due time and timelines are respectedEnsure accuracy and completeness of data entered into OPIS/Sponsor systems and ensure that the confidentiality of the patient is respectedPerform source data verification according to the Monitoring Plan or other similar documentsVerify that Adverse Events and Serious Adverse Events have been reported according to OPIS and/or Sponsor procedures and in adherence to regulatory requirementsEscalation of significant or critical issues according to the relevant proceduresManage queries on an ongoing basis and within the timeframes set
Qualifications
Degree in a scientific field0-12 Months of experience as CRAKnowledge of ICH‐GCP and ISO14155 and techniques for the monitoring of clinical studies and clinical investigationsObtain 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 informationGood knowledge of Office SuiteGood knowledge of English languageAble to work independently under the supervision of the Project Managers and Clinical Operations ManagersAble to interact with the personnel of clinical studies and clinical investigations
About UsFounded 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 OfferWe offer a competitive salary with other benefits/bonuses and opportunity to develop your professional career with an expanding and growing company.#J-18808-Ljbffr