(Senior) Clinical Research Associate (m/f/d) - Romania in Bucuresti

Location: Company’s office in Bucharest or home-based (hybrid model of work) Who we are?Optimapharm 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.With 27 strategically located offices, Optimapharm 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 a CRA III/Senior CRA to join our Clinical Operations team in Romania and 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 hoursWork from homeSummer work schedule  Who are we looking for? Qualifications and Experience University degree, preferably in medical or life sciences. Individuals 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 2-3 years of independent clinical trial monitoring experienceExperience in gastroenterology, oncology and dentistry, and start-up activities is an advantage High 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 advantageous Your 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 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 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. If you would be interested in joining the Optimapharm team, please send your CV in English and note that only shortlisted candidates that meet the requirements will be contacted for the further selection process.


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