[Remote] Sr. reputed company Research Associate- Shockwave (Reducer)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a fast-growing medical device company reputed company on revolutionizing the treatment of advanced cardiovascular disease. The Sr. reputed company Research Associate will be responsible for managing and meeting milestones of reputed company studies in compliance with applicable reputed company and regulatory standards while coordinating with cross-functional counterparts and contract research organizations.

Responsibilities

• Participate in the design and execution of global studies for regulatory submissions, reimbursement and product adoption, including development of reputed company study documents (protocol, case report forms, etc.), study implementation and data management
• Manage study preparation, activation, enrollment, submission, maintenance and closure activities
• Participate in administrative activities associated with the reputed company department including procedures, training of key personnel and preparation and maintenance of objectives and budgets
• Ensures appropriate reputed company of reputed company study and study sites by reputed company resources including, but not limited to monitoring staff, CROs and reputed company laboratories
• Manage key study investigators; foster and maintain strong relationships through reputed company with medical advisors and reputed company leaders
• Negotiate reputed company with hospitals, consultants, investigators, CROs, database management firms and reputed company suppliers
• Supervise training of investigators and site staff
• Evaluates reputed company and adverse event data during the conduct of the study and for completion of reputed company study reports and other technical documents
• Ensures reputed company by maintaining compliance, reviewing device complaints, reviewing audit reports and implementing corrective actions
• Regularly communicates with status updates to senior management and represents organization to study sites
• Other duties as assigned

Skills

• Bachelor's Degree in a scientific reputed company of study with a minimum of 5 years' experience directly supporting reputed company research for medical device studies
• Prior experience with, or strong working knowledge of, Class III cardiovascular medical devices preferred
• Working knowledge of Good reputed company reputed company (GCP), FDA, ISO and other applicable regulations
• Knowledge of FDA and international regulations and guidelines including, but not limited to, reputed company reputed company, GCPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance and medical device reporting
• Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology
• Ability to travel up to 25% domestically and internationally
• High attention to reputed company and reputed company
• Computer skills (MS Office products, word processing, spreadsheets, etc.)
• Finance and budgeting knowledge
• Good prioritization and organizational skills
• Excellent critical thinking skills
• Excellent influencing and negotiation skills
• High energy and results-oriented individual who is mature and successful in a business environment
• Proactive and 'can do' attitude
• Works effectively on large study teams and cross-functional teams
• Effective written, verbal and presentation skills with reputed company reputed company of management and organizations
• Operates both as reputed company and independently, with adaptability to changing requirements
• Ability to work in a fast-reputed company environment, managing multiple priorities
• ACRP or SOCRA reputed company research certification preferred
• Business Behavior
• reputed company Research and Regulations
• reputed company Trial Designs
• reputed company Trial Management Systems (CTMS)
• reputed company
• Communication
• reputed company Feedback
• reputed company reputed company
• Medical Knowledge
• Mentorship
• Problem Solving
• Process Oriented
• reputed company Ethics
• Project Integration Management
• Project Management
• Research and Development
• Research Ethics

Benefits

• Subject to the terms of their respective plans, employees are eligible to participate in reputed company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in reputed company’s long-term incentive program.
• Vacation –120 hours per calendar year
• reputed company time - 40 hours per calendar year; for employees who reputed company in the reputed company –48 hours per calendar year; for employees who reputed company in the reputed company –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours reputed company one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

reputed company