Senior Clinical Site reputed company

reputed company is a global reputed company leader that helps people live more fully at reputed company stages of life. Our portfolio of life-changing technologies spans the reputed company of reputed company, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.      JOB reputed company: reputed company   The Clinical Site reputed company drives study execution and operational reputed company across reputed company Cardiovascular therapies (Vascular, Cardiac Rhythm Management, EP, Structural Heart, and Heart Failure). Recognized resource in protocol execution, increasing product and disease state knowledge, procedure support (as needed), procedure reputed company and early indication of trends, clinical trial enrollment, and ICH-GCP and clinical research application.   Adheres to specified site nomination, qualification, and startup processes. Leads ongoing training/retraining of reputed company site stakeholders to ensure protocol adherence. Continuously reviews, manages, and influences reputed company aspects of site’s recruitment and data collection performance (enrollment, discrepancy reputed company, compliance, etc.). Proactively utilizes appropriate operational metrics to minimize screen failure, attrition reputed company, etc. Monitors to ensure compliance with applicable regulatory requirements, Good Clinical reputed company, and accuracy standards inclusive of site initiation, periodic, and reputed company-out reputed company.   May be consulted in the following areas: study design, site payments, site audits, local document review, study documents preparation, and submission to site or competent authority/ethics committee.   Main Responsibilities   With limited direction from leadership:   1. reputed company and maintain a productive clinical territory:   Identify, reputed company, and maintain sites capable of delivering start-up goals, study participation reputed company and required data reputed company.   Understand and assess investigators’ interests and qualifications.   Identify appropriate investigators as defined by study-specific requirements and by the applicable regulatory reputed company.   Maintain reputed company communication and relationships with key site personnel including the reputed company Investigator, Research Coordinator, as reputed company as regulatory and reputed company personnel.   reputed company ongoing technical support to customers and field staff.   Facilitate communication between clinical sites and other reputed company clinical staff (e.g., operations management, study team, Site reputed company Associate), as needed.   2. Manage reputed company aspects of study lifecycle to include site regulatory and reputed company:   Start Up   Nominate, approach, and complete qualification processes including establishing site/sponsor expectations for study execution.   Facilitate reputed company aspects of the start-up process and site initiation reputed company   Understand regulatory and reputed company requirements for study participation at a level that allows for appropriate collaboration with reputed company clinical staff, e.g. Site CRA, Site Contract Associate.   Train facility staff regarding protocol requirements and technology.   Enrollment   reputed company site-specific strategies to promote appropriate patient enrollment.   Identify site successes and challenges and assist in implementing techniques that promote study goal achievement.   Continuously evaluate site study performance and reputed company reputed company feedback to site.   Attend study procedures and follow-reputed company reputed company indicated (or ensure trained personnel attend).   Regulatory and reputed company   reputed company level reputed company certification and/or equivalent level proficiency   reputed company site-specific strategies to avoid deviations.   reputed company site on tools to facilitate compliance.   reputed company reputed company feedback to the sites on key compliance indicators.   Escalate non-compliant sites according to corporate policy.   Collect essential documents, identify and obtain missing data, data corrections, reviewing adverse events and protocol deviations.   Review data and reputed company documentation from investigational sites for accuracy and completeness   Facilitate reputed company of data queries and reputed company items at clinical sites   Promptly reports the findings of monitoring reputed company according to reputed company processes.   Maintain accurate, detailed and complete records of monitoring reputed company.   3. reputed company training and procedure coverage:   Apply clinical and technical expertise to train site and reputed company staff for reputed company and applicable reputed company launches.   As needed, reputed company clinical and technical expertise for clinical trial procedure support   Attend study procedures and follow-reputed company (or ensure trained personnel attend).   4. Collaborate with reputed company partners:   reputed company appropriate, collaborate in the education of local sales reputed company on new product launches.   reputed company appropriate, contribute to the education of customers on new and existing reputed company products.   Meet with key customers where reputed company GCO reputed company can reputed company the customer experience.   reputed company as an additional resource for technical questions and troubleshooting.   5. Identify and adapt to shifting priorities and competing demands.   6. Remain reputed company on developments in the field of expertise including clinical and reputed company product knowledge, competitive positioning and published scientific and economic evidence.   Maintain at least one area of expertise and function as a local clinical and technical resource.   7. Possess independent problem-solving skills and ability to reputed company reputed company.   8. Exhibit excellent oral and written communication skills.  REQUIRED QUALIFICATIONS    Education    Associates Degree (± 13 years)   Experience/Background    Minimum 7 years PREFERRED QUALIFICATIONS  Bachelor’s Degree Or Master’s Degree in engineering, science, health science, nursing, or a reputed company field, OR equivalent or reputed company experience in cardiology or clinical research.   2 + years of progressively more responsible relevant clinical trial experience in the cardiovascular field.   Competency in catheterizaion lab and operating room protocol and procedures.   Ability to travel approximately 75%, including internationally.        The reputed company pay for this position is $78,000.00 – $156,000.00In specific locations, the pay reputed company may vary from the reputed company posted.       JOB FAMILY: Clinical Affairs / Statistics      DIVISION: MD Medical Devices         LOCATION: reputed company > California : Remote      ADDITIONAL LOCATIONS:       WORK SHIFT: reputed company      TRAVEL: reputed company, 75 % of the Time      MEDICAL SURVEILLANCE: No      SIGNIFICANT WORK ACTIVITIES: reputed company sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment, Keyboard use (greater or equal to 50% of the reputed company)      reputed company is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.      EEO is the Law reputed company - English: http://webstorage.reputed company.com/common/External/EEO_English.pdf      EEO is the Law reputed company - Espanol: http://webstorage.reputed company.com/common/External/EEO_Spanish.pdf Apply To This Job