(Senior) Clinical Research Associate (s)CRA - sponsor-dedicated in Bucuresti

JOB DESCRIPTION Job Overview:(Senior) Clinical Research Associate (s)CRA - sponsor-dedicatedLocation: Home Office, RomaniaA formula for clinical innovation: Labcorp Drug Development. With comprehensive drug development services and de-identified data from 70 million patients worldwide, our 60,000 employees advance life-changing medicines across a wide range of therapeutic areas. In this role, you will work directly with one of our renowned key sponsors and advance the development of innovative, life-changing medications for oncological therapies.What we have to offer: a strong international support network, flexible working solutions that facilitate a genuine work-life balance, excellent career opportunities, a highly competitive compensation package and the opportunity to significantly raise your profile in the industry. If you are looking to broaden your therapeutic expertise whilst gaining exposure within a world-class pharmaceutical working environment, we are looking forward to meeting you!As (Senior) Clinical Research Associate, you typically will:Own all aspects of site management as described in the project plansEnsure the study staff conducting the protocol receive all materials and instructions to safely enter patients into the studyProtect study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirementsEnsure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible entriesPerform the required monitoring tasks in an efficient manner, according to SOPs and established guidelines; prepare accurate and timely trip reportsReview progress of projects and initiate appropriate actions to achieve target objectivesInteract with internal work groups to evaluate needs, resources and timelinesAct as contact for clinical trial suppliers and other vendors as assignedOwn the entire process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow ups on SAEsIndependently perform CRF reviewsGenerate queries and resolve issues according to data review guidelines on Labcorp or sponsor data management systems Assist with training, mentoring and development of new employees, e.g. co-monitoringEducation/Qualifications:Degree in a relevant field such as life sciences, biology, health care (management), nursing, pharmacology, (veterinarian) medicine, oecotrophology etc. In lieu of the above, a completed equivalent vocational education (e.g. study nurse, research nurse, study coordinator...) and/or equivalent professional experienceExperience:Proven experience in clinical research in a variety of therapeutic areas including oncologySolid independent monitoring experience in Romania as (Senior / Lead) CRA and familiarity with applicable local regulations and authoritiesAwareness of applicable clinical research regulatory requirements such as local regulations, GCP / ICH and the Romanian regulatory authorities landscapeWorking knowledge of Microsoft Word, Excel and PowerPointEffective time management and organizational skills and a keen attention to detailAbility to establish and maintain effective, trustful working relationships with internal and external stakeholdersExcellent communication skills in both Romanian and English - spoken and written - are a mustRemote#LI-AR1