Description
At Align 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.
This Clinical Research Associate- Contractor is responsible for monitoring and tracking patients in clinical studies at Align Technology and ensure that the studies are conducted according to protocol. The process includes interaction and communication with clinical sites, private-practicing orthodontists, and treatment coordinators related to case specific issues and status.
Essential Duties and Responsibilities (Other duties may be assigned)
- Monitor and tracks patients in clinical sites.
- Ensuring adequate documentation and proper implementation of written protocols.
- Severs as a liaison between Align Technology and the study site, investigators, study coordinators, staff members.
- Data collection of clinical research cases.
- Assists in writing and developing clinical protocols, data and tracking forms, informed consent documents, and clinical report forms.
Additional responsibilities
- Provides 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.
- Oversees delivery and shipment of aligners for clinical studies.
- Assists in writing annual and final clinical study reports.
- Ensures accurate, up-to-date records of all documents and protocols of all clinical studies.
- Follows all departmental and company procedures as indicated in quality, administrative, or other systems.
- Ensures 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 25%.
- Perform other duties as assigned.
Educations and Experience
- Bachelor’s degree in Science or equivalent years experience.
- 0-1 year experience as a Clinical Research Associate.
- Medical device experience required.
Skills Required: Language Skills
- Ability to think critically and scientifically.
- Ability to give presentations and updates on clinical research.
- Ability to write clinical reports and protocols.
- Ability to communicate effectively.
Mathematical Skills
- Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.
Reasoning Ability
- Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.