Assoc Clinical Research Spec Medtronic 2,429 reviews - Northridge, CA Careers that Change Lives The Diabetes Group is working with the global community to change the way people manage diabetes. Together, we will transform diabetes care by expanding access, integrating care, and improving outcomes; so people with diabetes can enjoy greater freedom and better health. A Day in the Life The Associate Clinical Research Specialist (ACRS) is responsible for supporting clinical activities related to one or more clinical studies and performing/managing the daily field operations associated with support of the assigned studies. Responsibilities may include the following and other duties may be assigned. * Support Clinical Research Specialist (CRS)/Clinical Study Manager (CSM) to ensure successful conduct of assigned clinical studies consistent with applicable regulations, guidelines and policies. This may involve multiple regulatory requirements, based on location of study conduct. * Attend study team meeting, take minutes and follow up on action items. Assist CRS/CSM in meeting preparation, as needed * Assist in the development and updates of study-related materials and plans (training materials, study plans, patient materials, etc) and ensure appropriate approvals before implementation * Maintain trackers for and file documents for sponsor and site training, IRB approvals, site documents (CV, medical licenses, etc), and monitoring activities * Maintain trackers for management of study enrollment * Assist in tracking site initiation and activation activities * File all study documents (general and site documents) in the Trial Master file (TMF, paper and electronic study files as requested), track study documentation in TMF, assist in conducting TMF reviews, ensure proper documentation of TMF reviews * Oversees, designs, plans and develops clinical evaluation research studies. * Prepares and authors protocols and patient record forms. * Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential. * Oversees and interpret results of clinical investigations in preparation for new drug device or consumer application. * Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations, and may prepare clinical trial budgets. * May be responsible for clinical supply operations, site and vendor selection. Must Have: Minimum Requirements * Bachelor's Degree * Minimum of 1 years work experience or Advanced degree with 0 years work experience * Experience in clinical or clinical research/studies/operations * Experience in healthcare industry (e.g., medical device, biotechnology, pharmaceutical, life sciences, hospital, research centers/universities, or physicians office) Nice to Have * Bachelors degree in Sciences * Experience with regulatory compliance guidelines for clinical trials * Knowledge of Diabetes * Experience with Good Clinical Practice (GCP) * Good written and oral communications skills, with proficient knowledge of medical terminology. * Experience in working in cross functional environment, with Research and Development, Regulatory, International and Legal organizations. * Proficiency in word processing, spreadsheets applications (e.g., MS Word and Excel) * Experience in clinical trials, industry experience (medical device preferred) * Attention to detail and accuracy and ability to manage multiple tasks. * Strong verbal and written communication skills, technical and problem solving skill * Able to read, analyze and interpret general business documents, technical procedures, and specifications * Able to work effectively, independently and on cross-functional teams * Able to write reports, business correspondence and procedure manuals effectively * Able to frequently use general knowledge of industry regulations, practices, techniques, and standards