Clinical Research Associate Ii/Iii

?? Location: located in North Italy; Milan??Who we are?Optimapharm is aglobally operating, leading, mid-sized, full-service CROaiming to deliver new therapies to improve and save patients' lives.Optimapharm' s key priorities are the well-being of our people, consistent quality delivery to our clients and healthy, sustainable growth.With 26 strategically located offices, Optimapharm operates in 40+ countries, providing most optimal access to Patients and Investigators globally.Established nearly 20 years ago, we leverage our experience, stable project teams and collaborative, and flexible approach to secure a high level of repeat business, gain the trust of new customers and secure continued growth of the company.We're expanding our team in Italy and looking for anew CRA (CRA II - III, depending on experience).Whether you're building your expertise as a CRA I or ready to step into a higher CRA role, this is your chance to shape the future of clinical research - delivering excellence for our sponsors and meaningful impact for patients and families worldwide.This role sits within a defined CRA career path: CRA I ?CRA II ? CRA III? Senior CRA.?? What do we offer?Working in a successful company that's growing and developing every dayWorking with a highly experienced team of clinical research professionalsPerformance bonusReferral bonusFlexible work hoursHome-based positionWorking from home allowanceMeal vouchersShopping discountsEmployee engagement programsWell-being initiativesTraining and development program?? Who are we looking for??? Qualifications and ExperienceUniversity degree,preferably in medical or life sciences;nursing education or other relevant healthcare college degreeAt least2 - 3yearsof independent clinical trial monitoring in a CRO/pharmaAt least 1,5 year of experience in oncology (solid tumors); gastroenterology experience would be considered as a plusMandatory: certified CRA in accordance with the Italian Ministerial DecreeHigh level of knowledge of ICH GCP Guidelines, knowledge of regulatory requirements and a strong interest in clinical researchComputer proficiency is mandatoryAbility to read, analyze, and interpret common scientific and technical journalsExcellent verbal and written communication skillsVery good interpersonal and negotiation skillsAbility to work independently, pro-activeAffinity to work effectively and efficiently in a matrix environmentA current, valid driver's license?? Your responsibilitiesPerform routine site visits independently, including pre-study, initiation, interim monitoring and closeout visitsManage assigned sites by regular contact with site personnel to ensure site compliance, adequate enrolment and understanding of study requirementsIndependently perform CRF review; query generation and resolution against established data review guidelines or data management systems as applicableIdentifying and escalating potential risks and identifying retraining opportunities for site personnelPreparation of corrective and preventive (CAPA) plans for issues identified during monitoring activities and pro-active follow of each, individual CAPA until timely resolutionPreparation of documents required for EC submissions and notifications, translation of study-related documents (where applicable), and other tasks as instructed by the supervisorIndependently negotiate study budgets with potential investigators/institutions and assist with the execution of site contracts as applicableAdministration of site payments in accordance with relevant project instructionsBy joining our fast-growing and prosperous team, you will have an excellent opportunity for further personal growth and career development.If you would be interested in joining the Optimapharm team, pleasesend your CV and note that only shortlisted candidates who meet the requirements will be contacted for the further selection process.Compensation is competitive and final offers will reflect each candidate's experience, skills, and qualifications.Disclaimer: Unsolicited CVs sent to Optimapharm (Talent Acquisition Team, Hiring Managers or any other OPT employee) by recruitment agencies will not be considered for this role.Optimapharm follows a direct sourcing strategy and collaborates exclusively with selected recruitment partners when external support is required.#J-*****-Ljbffr