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Clinical Research Assistant – Clinical Research (Barretos – São Paulo)

JOB DESCRIPTION What if you could join the team of an institution whose core values are based on love and humanization? Hospital de Amor has several hospital units, believes in its team, and constantly develops its employees, promoting a positive organizational climate and well-being in the workplace. Our mission is to provide services to patients of the Unified Health System in prevention, diagnosis, treatment, education, and oncology research. We are looking for a professional for the position of **Clinical Research Assistant**. Learn more: **MAIN RESPONSIBILITIES OF THE POSITION** ; ;Work in compliance with national and international clinical research regulations and current resolutions. ; Collaborate with the study coordinator in managing and monitoring the study. Schedule exams according to protocols/medical requests. Schedule patient follow\-ups in the system; issue the daily research schedule; verify medical records/system. Prepare all documentation for sending materials (biological samples and images) and schedule shipments. Control biological samples for storage and/or shipment. Keep the system updated by recording all patient\-related activities (informed consent form signature; visits; exams; etc); Review each medical record, identify and/or request pending exams, and file them so that the record is complete before the medical consultation. If any exam is not ready, an observation must be left on the front page of the record stating that it has been requested (date and time). Check protocol material inventory and request replenishment. Request results reports for radiological exams, ECGs, and other tests performed by study participants. Submit requests to the pathology archive to separate the clinical research patient's material and retrieve it from the service. The material must be delivered immediately to the study coordination. File clinical study documents when delegated by the study coordinator. ;Prepare cover sheets for fax, mail, correspondence, and submissions to the Ethics Committee (CEP) and forward them to the responsible person for review and signature. ; Perform other clinical research assistant duties as assigned within the study, in agreement and authorized by departmental coordination. ;Manage expense reimbursements for study participants, such as meals, accommodation, and transportation, together with the start\-up team. ; ;Fill out all internal spreadsheets as required by the site in coordination with the study coordinator. ; Support the completion of all sponsor platforms (CRF, IWRS, etc.) and resolve outstanding issues within established deadlines. Work in compliance with national and international clinical research regulations and current resolutions. Initiate first contact upon arrival of a new clinical study at the unit via the feasibility email. Assist the investigator in completing feasibility questionnaires with the principal investigator and forward them to the respective sponsors. Organize essential study documentation according to the initial study package along with the coordinator when required, concluding the start\-up/regulatory process. Carry out the preparation of center documents for each study, which must be followed by initial submission to the CEP/CONEP system. Prepare and submit protocol amendments to CEP/CONEP, as well as notifications, safety reports, and other documents required by the study. Responsible for obtaining written and dated favorable approval or opinion from the Ethics Committee (CEP) for the study protocol, investigator's brochure, informed consent form, updates to the informed consent form, patient recruitment procedures (e.g., published advertisements), and all other information to be provided to the patient in the study. Support the Center Qualification Visit, responding to queries from monitors and/or managers, and presenting the Hospital and its facilities. Establish direct communication with the Ethics Committee (CEP) regarding research protocols, assist in resolving ethical issues in coordination with sponsors, and provide the CEP with all research documents subject to ethical review. Respond to questions raised by sponsors throughout the entire start\-up phase of the research protocol. Work in compliance with national and international clinical research regulations and current resolutions. Participate in all Initiation Visit (SIV) meetings, post\-SIV meetings, multidisciplinary meetings, departmental meetings, meetings with investigators and sponsors, recruitment meetings, and training sessions. Attend meetings with sponsors when summoned. Manage corporate email and recruitment.pesquisaclinica@hcancerbarretos.com.br. Develop, implement, and analyze recruitment strategies tailored to each clinical study to identify potential candidates. Identify, monitor, and flag potential candidates for clinical studies in the Tasy system and physically on the patient's card, as well as perform double verification of eligibility criteria when indicated by another team member. Follow up with specialties in the outpatient clinic, assisting in the selection of new patients. Communicate and coordinate with supporting research departments such as pathology, molecular biology, oncogenetics, radiotherapy, interventional radiology, among others, whenever necessary. Assist the coordination team and medical staff with scheduling and signing Informed Consent Forms (ICF) and others, when needed. Create supportive tools for clinical studies for internal and external dissemination. Develop, manage, and share internal announcements, brochures, newsletters, folders containing current eligibility criteria and active ICFs, aiming to keep the medical team continuously updated about open clinical studies for recruitment. Manage and disseminate monthly data to the medical team through a newsletter. Manage WhatsApp groups for each specialty with internal physicians and those from other Hospital de Amor (HA) units such as Jales, Porto Velho, Campinas Prevention Unit, among others, to strengthen communication and sharing of updated clinical protocol information. Guide medical residents in recruiting potential candidates for clinical studies according to eligibility criteria. Conduct monthly recruitment indicators assessment, analyze, and report to the Clinical Research Department. ;Review/update Recruitment Standard Operating Procedures (SOP). ; **REQUIREMENTS AND QUALIFICATIONS** High School Diploma Required; preferably a student in the health field; Good Clinical Practice knowledge; Basic English proficiency desirable; Proficiency in Microsoft Office; Computer skills; **WORK HOURS** ; From 08:00 to 18:00, Monday to Friday\-feira.

Pr. Francisco Barreto, 99 - Centro, Barretos - SP, 14780-059, Brazil

Negotiable Salary