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Clinical Operations Assistant

Company: Align Technology
Location: San Jose
Posted on: May 3, 2021

Job Description:

Join a team that is changing millions of lives.

Transforming smiles, changing lives

AtAlign Technology, we believe a great smile can transform a person's life, so we create technology that gives people the confidence to take on whatever's next. We revolutionized the orthodontic industry with the introduction of the Invisalign system, and we have never lost sight of that spirit of innovation. Our diverse and collaborative teams are constantly pushing the boundaries of what's possible.

Ready to join us?

About this opportunity

The Clinical Operations Assistant is responsible for providing overall clinical activities administration and support to the Clinical Affairs team in accordance with regulatory and company standards. Clinical activities include assisting with conducting studies that are according to protocol or other documentation needed for projects, interaction and communication with clinical sites, private-practicing orthodontists, and treatment coordinators.

In this role, you will

  • Successful conduct of assigned clinical investigations consistent with all applicable regulations, guidelines and policies
  • Perform / oversee site initiation activities, including, but not limited to, clinical trial agreement negotiation support and IRB/EC approval process
  • Assist with data management and review of clinical data/ information as needed
  • Provide support to facilitate clinical study payment processes
  • Support and monitor clinical study device-management, shipment and tracking process as required
  • Work closely with internal and field-based study project teams to provide clinical study support with an emphasis on site management, device management and start-up activities
  • Consult with clinical research organizations, vendors or equivalent as required to ensure appropriate management of external study specific resources
  • Provide administrative support for investigator meetings, congresses, etc.
  • Work in conjunction with Clinical Data Associates, Clinical Research Associates, Clinical Project Managers, and others on the Clinical Affairs team on the CRF design process utilizing existing data form standards
  • Assist with data collection, data transfer and data review for R&D engineers
  • Create and maintain tools for tracking and inventory of various clinical activities
  • Provide assistance to the clinical research team by organizing files, projects, data, etc.
  • Assist with the development and execution of clinical research activities and programs
  • Work under specific instructions to assist with routine projects, and procedures
  • Perform literature searches, research and overall project assistance
  • Assist the Clinical Affairs team with monitoring and tracking patients in clinical activities
  • Perform other duties as assigned

Additional responsibilities:

  • Track, and create reports and documents necessary for clinical activities, both in-house and from participating study sites
  • Oversee delivery and shipment of items needed for orthodontists and general dentists
  • Follow all departmental and company procedures as indicated in quality, administrative, or other systems
  • Ensure the effective fulfillment of objectives and deadlines assigned to the group
  • Comply with all safety policies, practices and procedures. Report all unsafe activities to supervisor and/or Human Resources
  • Participate in proactive team efforts to achieve departmental and company goals.
  • Travel may be required - up to 10%
  • Perform other duties as assigned

In this role, you'll need

EDUCATION and/or EXPERIENCE

  • Bachelor's degree or equivalent experience in the sciences or health field is required
  • Experience in device or pharmaceutical clinical trials is required
  • Strong computer skills including electronic data capture (EDC) is required
  • 1-4 years of experience in clinical research preferred
  • Familiarity with clinical trial design and analysis issues preferred

SKILLS REQUIRED: LANGUAGE SKILLS

  • Ability to think critically and scientifically
  • Ability to give presentations and updates on clinical projects
  • Ability to write and produce reports and queries
  • Ability to assist and support statisticians with data analysis
  • Strong communication, interpersonal and problem solving skills
  • Self-motivated with excellent time management skills
  • Exceptional organizational, interpersonal, and presentation skills
  • High proficiency with MS Office (Word, Excel, Powerpoint, Outlook), internet
  • Team Player,
  • Prior experience of clinical trial and international regulatory processes including FDA, ICH, and ISO:14155.

WORK SCHEDULE / HOURS

Regular business hours

Sound like a good fit?

Great! Click the "Apply" link to let us know you are interested. Not the right fit? Don't worry,Alignis quickly growing so we are creating more opportunities to expand our Align family. Please consider joining our Talent Network to receive notifications about future jobs or sharing this opportunity with others in your network.

About Align

Align Technology is a publicly traded medical device company that istransforming smiles and changing lives. Our global team of talented employees develop innovative technology, tools and treatment options to help dental professionals worldwide achieve the clinical results they expect. Our digital ecosystem combines the power of technology to create beautiful smiles through the integration of AI and machine learning, digital imaging and visualization, biomechanics and material science to develop the Invisalign system, the most advanced clear aligner system in the world; iTero Intraoral Scanners andOrthoCADdigital services. Did you know? Align is the world's largest manufacturer of custom 3D-printed materials.

By joining Align, you will be part of a global, fast-growing company in one of the most dynamic industries. Great people, innovative technologies, and meaningful work - these are just some of thethingsemployees say make Align Technology a great place to work.

We respect your privacy. Please reviewour Applicant Privacy Policies for additional information.

Global Diversity Statement:

At Align, we believe in the power of a smile, and we know that every smile is as unique as our employees. As we grow, we will continue building a workforce of diverse cultural backgrounds and life experiences and fostering a culture of open-mindedness and compassion for all our employees. We live our company values by promoting healthy people and healthy communities. All with the intent of changing millions of lives, one unique smile at a time.

Equal Opportunity Statement

It is our policy to provide equal employment opportunity in all of our employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Align must be legally authorized to work in the country which they are applying for and verification of employment eligibility will be required as a condition of hire.

Keywords: Align Technology, San Jose , Clinical Operations Assistant, Other , San Jose, California

Click here to apply!

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