Job Title: Clinical Research Associate II
Change people’s lives and love what you do! Cochear develops world-leading medical devices that help people hear. As the top 100 medical device company and market-leader in implantable hearing devices, more people choose a Cochlear-branded cochlear implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives.
About the role
In order to help Cochlear ensure compliance with regulatory requirements, we are recruiting for a Clinical Research Associate II in our Cochlear America’s head office based in Centennial, Colorado.
To be successful in this role you will be part of a team that is integral to our clinical research. In this role you will provide support for assigned clinical trials, ensuring compliance with Good Clinical Practice (GCP), Good Documentation Practices (GDP) and all applicable regulatory requirements. You may have some clinical research experience, with cochlear implants or other medical devices, and are familiar with submission of Institutional Review Board (IRB) and Food & Drug Administration (FDA) Investigational Device Exemption (IDE) applications. You demonstrate excellent organization and customer service skills and are comfortable communicating with key stakeholders internally and externally. You have outstanding attention to detail and are accustomed to following through on assigned tasks. Through your effective communication skills you will also be able to influence and support others to complete their tasks according to an assigned project plan. You enjoy working with data and demonstrate accuracy when reviewing it.
In this role you'll have the opportunity to make a significant contribution to Cochlear's successful history of innovation by applying your knowledge of medical device clinical research and exceptional organizational skills. Success with this program will support the transformation of implantable hearing for a growing population of over 550,000 people across more than 100 countries.
The Clinical Research Associate II is an in-house role responsible for supporting all aspects of clinical trials including implementation and support to ensure compliance with GCP, GDP, and other regulatory requirements.
Responsibilities include but are not limited to:
- Organization and submission of IRB applications
- Planning and support of investigational site training
- Support of study approval through the study start-up process including site qualification initiation
- Maintenance of clinical research site files including IRB approvals, Investigator documents, study training materials, clinical monitoring documentation, adverse events, and trial correspondence
- Support the clinical studies team monitoring schedule
- Assist with the development of clinical trial materials including investigational manuals, evaluation materials, and databases
- Receipt, data entry and/or verification of clinical trial data including adverse events
- Maintenance of clinical study financial records including site, subject and IRB payments
- Investigational device logistics and tracking
To add value to Cochlear in this role you'll be able to demonstrate the following skills and experience in your application and at interview:
- Minimum Bachelor’s degree in Health Sciences, Communication Sciences and Disorders, Nursing or equivalent.
- 2 to 4 years medical device clinical trial experience.
- Ability to collaborate cross functionally with internal and external key stakeholders including the clinical studies team, data management, clinical site investigators, global clinical and other internal customers (e.g., Legal, Marketing, Regulatory, Finance).
- CRA Certification from ACRP, SOCRA or equivalent.
- Proficient in Good Clinical Practices and applicable medical device regulations including the Code of Federal Regulations and ISO14155.
- Must be proficient in using various PC-based software packages including Outlook, Word, and Excel.
- The incumbent must possess excellent verbal and written communication as well as interpersonal, facilitation, presentation, and organizational skills.
- Excellent attention to detail and ability to work in a fast paced environment.
- The incumbent must be able to work independently on defined work assignments and be able to effectively communicate risk management issues
Apply now by completing your application form online. Cochlear is an equal employment opportunity organization. Applicants must meet the job specific application criteria to be considered.
Working at Cochlear Americas:
- Work with dedicated and passionate colleagues to help more people hear
- Highly collaborative global team environment
- Opportunities for growth and development
- Competitive salary and bonus
- Comprehensive benefits including medical, dental, vision, life insurance, retirement plans, paid holidays/vacation, tuition reimbursement, and extended Paternity Leave.
- State of the art facility with great work/life balance conveniences (onsite gym, wellness programs, dry cleaning services, company-sponsored monthly food truck and more!)
Cochlear pioneered and is the global leader in the research and development, manufacture and marketing of implantable hearing solutions. Cochlear’s global headquarters is located in Sydney, Australia where we design and manufacture the leading cochlear implant devices in the world. A success story in the commercialization of R&D, Cochlear has more than 60% share of the global market, employs more than 3,500 people worldwide, operates directly in over 20 countries and sells in over 100 countries. Over 550,000 people across more than 100 countries now experience hearing as a recipient of a Cochlear hearing solution.
As a world-leader in innovative medical devices, Cochlear encourages continuous learning for employees. Visit www.cochlear.com/careers for more information.
Cochlear Americas is an Equal Opportunity, Affirmative Action Employer and provides equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, marital status, veteran status, or any other characteristic protected by federal, state or local law. In addition, Cochlear will provide reasonable accommodations for qualified individuals with disabilities. If you require accommodation with completing the online application, please contact us via web or phone at 303-264-2349.