Location: Brazil Who We Are Science as a tool. People as inspiration. Intrials is a disruptive company with all the attributes that a CRO must master. We mix innovative projects with the necessary skills to provide a full service. Nothing stops us in the search for knowledge. Transforming people's lives through science tackling the challenges of our clients' projects in a focused and exclusive fashion. People are indeed our main asset. We work tirelessly to pilot and monitor Clinical Research projects since the beginning. We guarantee connection, innovation, and security in solutions for the entire health chain. Diversity & Inclusion are essential to continue building our history of innovation. Diversity of color, belief, sexual orientation, religion, or any other characteristic are very welcome in all open positions at our company. It is a fundamental part of Intrials to constantly think and implement actions that reinforce the importance of good coexistence with all the people who are part of our DNA and together, to leverage and build true impactful results in our society. All about people, purpose and science. Primary responsibilities include, but are not limited to: Ensure that the clinical study is conducted according to the ICH-GCP guidelines, the local and international regulations as well as according to Intrials or Sponsor's SOPs; Ensure that clinical study data are accurate and verifiable; Identify and perform the corresponding quality controls on source documents. Perform monitoring activities and visits (on-site and / or remote): Site Selection; Visit (SSV), Site Initiation Visits (SIV), Interim Monitoring Visit (IMV) and Close-out Visit (COV); Participate in meetings / teleconferences with the Sponsor and PM; Act as the main point of contact for study sites; Provide support to PM and more experienced CRAs in the study coordination as applicable; Perform coaching activities for less experienced CRAs. Primary activities include, but are not limited to: Assist the PM and more experienced CRAs in project coordination, planning and logistics; Assist the PM and CRAs to prepare material to study meetings (e.g., kick off meeting, investigator's meeting, monitor's meeting, teleconferences), if applicable; Schedule plan and present training meetings for investigators and other investigative site staff during study conduction, whenever needed, ensuring that the site staff are in full knowledge and prepared to conduct the trial; Review or prepare all necessary operational documents and information required for Site Initiation Visit; Review or prepare the Investigator Site File (ISF) to be submitted to the Investigator prior or during the Site Initiation Visit; Prepare and conduct Pre-Study, Initiation, Interim Monitoring and Close-out Visits; Complete/collect all required documentation prior, during or after these visits' conduction and follow-up the visit's findings until the resolution with the sites; Attend local and / or international investigators and CRA meetings; Implement and document the Quality Control (QC) performed during the clinical study; Verify that drug management (accountability, dispensation, storage, etc.) is being done according to the procedures specified in the corresponding protocol and that everything is fully documented when study-blinding conditions allow, or accordingly with unblinded monitoring instructions. Verify if study blinding procedures are being performed as required, that subjects' identity is being kept in confidentiality; Verify if subjects' informed consent forms are being obtained according to the regulations; Assure the safety of the study participant reviewing all SAEs occurred in the trial, and AEs according to the monitoring plan of the study; review the TMF (including investigator file) to check if it is completed, updated, and organized; Assist in obtaining all regulatory documentation from the investigational sites during study start-up and conduction to support regulatory team for submissions to Health Authorities, Ethics Committees and Sponsor, if applicable; Be the line of communication between the Investigators and the Sponsor under Project Manager's supervision; In case of an audit / inspection, assist making the necessary arrangements between the study site and the auditors / inspectors to facilitate that audit / inspection related tasks can be conducted in an easy and smoothly way; Establish and follow up CAPA when applicable with the support of the PM or a more experience CRA; Assist in the revision of the SOPs related to the department activities; Review the payment of the investigator and the reimbursement of subjects according to the activities performed on the site and request PM to approve the payments; Assist with training and development of less experience CRAs and new employees, as applicable; Attend local and / or international courses / meetings to improve / acquire new skills. Requirements: Degree in Health Sciences or equivalent (Pharmacy, Biology, Biomedicine, Nursing, other); Relevant experience in Clinical Research as a CRA at CRO, ARO or pharmaceutical company is required; Available to travel considerably and ability to manage travel schedules; Knowledge of ICH-GCP, local and international guidelines; Advanced knowledge of English.
