Align Technology is a global medical device company that pioneered the invisible orthodontics market with the introduction of the Invisalign system in 1999.  Today, we develop innovative, technology-rich products such as Invisalign aligner treatments, iTero™ intra-oral scanners, and OrthoCAD digital services to help dental professionals achieve the clinical results they expect and deliver effective, cutting-edge dental options to their patients.

SUMMARY
This position is responsible for monitoring and tracking patients in clinical studies and pilots at Align Technology and ensuring that the studies are conducted according to protocol. Studies may also include treatment outcome collection programs with private practice doctors and/or universities.  The process includes interaction and communication with clinical sites, study participants, universities, and treatment coordinators related to case specific issues and status.

The senior research associate position is also responsible for development and oversight of integrating clinical research system improvements for enabling greater research efficiencies and improved throughput.  As such, cross-functional project management and leadership skills are required.

ESSENTIAL DUTIES AND RESPONSIBILITIES 

• Monitor and track patients in study sites and treatment outcome collection programs.
• Ensure adequate documentation and proper implementation of written protocols.
• Serve as a liaison between Align Technology and the study site, investigators, study coordinators, and staff members.
• Data collection of clinical research cases and outcome programs.
• Assist in writing and developing clinical protocols, data tracking forms, informed consent documents, and clinical report forms.  Secure approvals from regulatory and/or legal as needed for the program.
• Provide technical guidance to interns assigned to clinical study and/or outcome collection projects.
• Provide technical assistance to study sites regarding the conduct of clinical research
  Track data report forms, reports, and documents necessary for completion of clinical study, both in-house and from participating study sites.
• Ensure timely delivery and shipment of aligners and other necessary project materials needed for clinical studies and case collection programs, including study incentives.
• Assist in reviewing progress and/or final clinical study reports and treatment outcome reports.
• Ensure accurate, up-to-date records of all documents and protocols of all clinical studies.
• Follow all departmental and company procedures as indicated in quality, administrative, or other system documents.
• Ensure the effective fulfillment of objectives and deadlines assigned to the group.
• Ensure that milestone payments are made according to protocol and budget timeline.
• Comply with all regulatory and 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 (e.g. roadmap initiatives).
• Travel may be required – up to 5%
• Evaluate clinical research systems and identifies bottlenecks and scope ways for improvement.
• Develop cross-functional process flow charts to ensure they coincide with production processes.
• Assist with design, development, and execution of research system improvement requirements.
• Identify and analyze potential risks and benefits of new system upgrades.

Additional responsibilities:

 Other duties may be assigned

QUALIFICATIONS

• Team player with strong oral & written communication skills
• Excellent problem-solving skills, thoroughness, attention to detail

EDUCATION and/or EXPERIENCE

• Bachelor of Science, or equivalent experience required
• Masters of Science preferred
• 2+ years of experience as a Clinical Research Associate
• Experienced in designing and running pre-market and post-market clinical studies for medical device companies (including IRB determination and submission all the way through closure of the study)
• Dental industry experience preferred

WORK SCHEDULE / HOURS

Regular business hours

All your information will be kept confidential according to EEO guidelines.