Who we areOptimapharm is a leading, mid-sized, full-service CRO working across Europe and North America to deliver new therapies to improve and save patients’ lives. Optimapharm’s key priorities are our people and consistently exceeding our client’s expectations.With27 strategically located officesOptimapharm operates in 40+ countries, giving unrivaled access to Patients and Investigators in all countries in Europe and North America.In-depth expertise and long-standing experience, combined with a flexible and collaborative approach, allow optimization of design and planning; through its strong track record of delivery excellence and committed and stable project teams, Optimapharm has secured a high level of repeat business over the years.We are looking for aCRA III / Seniorto join ourClinical Operations team in Italyand support us in making a tangible difference to project sponsors and benefiting patients and their families all around the world.What do we offer?Working in a successful company that’s growing and changing every dayWorking with a highly experienced team of the clinical research professionalsInternational projects and professional growthPerformance bonusTraining opportunitiesFlexible work hoursHome-based positionSummer work scheduleWho are we looking for?Qualifications and ExperienceUniversity degree, preferably in medical or life sciencesIndividuals with a university degree in biotechnical, technical, bio-medicinal, social, or humanistic sciences must have a nursing education or other relevant healthcare college degree.At least 3 years of independent clinical trial monitoring experienceExperience in oncology and start-up activities is an advantageHigh level of knowledge of ICH GCP Guidelines, knowledge of regulatory requirements, and a strong interest in clinical researchFluent in local language and English, both written and verbalComputer 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 with minimal supervision, pro-activeAffinity to work effectively and efficiently in a matrix environmentExcellent numerical skills and reasoning abilityA current, valid driver’s license would be advantageousYour responsibilitiesPerform routine site visits with minimal guidance, 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 applicableIdentify and escalate potential risks and identify retraining opportunities for site personnelPrepare corrective and preventive (CAPA) plans for issues identified during monitoring activities and pro-active follow of each, individual CAPA until timely resolutionPrepare documents required for EC submissions and notifications, translation of study-related documents (where applicable), and other tasks as instructed by the supervisorWith minimal supervision, 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
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