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Clinical Trial Assistant

Company: Black Enterprise Magazine
Location: Belgium
Posted on: June 12, 2021

Job Description:

Associate Clinical Research Monitor Belgium Associate Clinical Research Monitor Belgium Location: Belgium Requisition #: 210008Q0 Post Date: Apr 07, 2021 Careers that Change Lives The Associate Clinical Research Monitor is responsible for the oversight of clinical research conducted at investigational sites to ensure compliance with study protocols, applicable regulatory standards, Ethics Committee/Institutional Review Board (IRB/EC) policies and procedures and business policies. This position works under supervision as needed, working closely with study teams, site personnel, Medtronic field personnel and monitoring supervisor for resolution of site issues. Responsibilities + Perform monitoring progress of clinical trials at the site level or headquarters and ensures that they are conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP), and other applicable regulatory requirements. + Develop and maintain liaison with clinical investigators, clinical research organizations (CRO), affiliated hospitals, and research institutions to initiate and expedite clinical studies on products that have investigational new drug or medical devices approval. + Be responsible for reviewing adverse event cases with investigators, determining and monitoring time, budget, schedules, preparing study documents, and issuing status reports. + May assist with design, development, and monitoring of clinical evaluation projects. + Train investigators and site personnel. + Including headquarter and field clinical research associates (CRA). + Implement and prepare the clinical development strategy as outlined by the clinical teams. + May contact and recommend qualified investigators Must Have + Bachelor or Master degree in life sciences, nursing or other health related disciplines. + Experience in Clinical Research related activities such as Clinical Trial Administration, Handling of Investigational products preferred. + One (1) year of Clinical Research monitoring preferred. + Fluent in French and English, Dutch is also preferred. Nice to Have + Capable of clearly and effectively communicating verbally and in writing. + Good interpersonal skills. + Ability to work in a fast paced environment. + Competencies and essential skills in the following: cross functional relationships, decision making, execution/results/process improvement, customer satisfaction. + Demonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands. + High attention to detail and accuracy. + Good problem solving skills. + Experience with word processing, spreadsheets, and databases applications (e.g., Word and Excel). + Basic understanding of any applicable regulations (e.g., Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive, etc.). + Business knowledge or experience with the medical/healthcare industry. + Knowledge of medical terminology. + Regulations/standards training. Your Answer Is this the position you were waiting for? Then please apply directly via the apply button! About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives.Help us shape thefuture. Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together. Diversity Inclusion At Medtronic, you will find a diverse team of innovators who bring their unique backgrounds and their individual life experiences to work every day. We work hard to cultivate a workforce that reflects our patients and partners, we believe its the only way to drive healthcare forward. We want to attract a diverse workforce, regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, veteran status, or any other characteristic protected by state or local law.Join us and bring the power of your point of view to our culture of collaboration and innovation. It is through strong diversity, inclusion and engagement that we can remain a leader in medical technology and solutions. And by embracing everything you have to offer your unique perspectives, talents and contributions we can live up to the promise of our Mission.It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

Keywords: Black Enterprise Magazine, Milwaukee , Clinical Trial Assistant, Other , Belgium, Wisconsin

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