Clinical Research Associate II
Change people’s lives and love what you do! Cochlear is the most recognized brand in hearing health care.
Human needs have always been our inspiration, ever since Professor Graeme Clark set out to create the first multi-channel cochlear implant because he saw his father struggle with hearing loss. We always start with people in mind – thinking about their needs.
For this reason, our products, services and support will continue to evolve and improve. We are by our customers’ side through the entire hearing journey, so they can experience a life full of hearing. 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 and working in an organization where they can be part of bringing the mission to life each day.
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 Lone Tree, 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 must have a strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials, experience with Food & Drug Administration (FDA) Investigational Device Exemption (IDE) clinical trials, either with cochlear implants or other medical devices, and are familiar with submissions to Institutional Review Boards (IRB). 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.
- Supports operational aspects of clinical trials, including contract and budget negotiation, evaluates the site, completes site qualification and initiation visits.
- Assists with the development of study materials (including, but not limited to training slides, Monitoring Plans, Communication Plans, Safety Data Handling Plans, Informed Consent Forms and study binders).
- Organizes, reviews, and submits IRB/EC applications.
- Prepares and maintains Trial Master Files (including study files, country files (as applicable) site files and subject binders).
- With oversight, supports internal departmental quality compliance (through adherance to SOPs, GDP, GCP, and applicable regulations, standards and guidances (e.g. 21 CFR, ISO 14155, etc.).
To add value to Cochlear in this role you'll be able to meet and demonstrate the following knowledge, skills and abilities in your application and at interview:
- Minimum Bachelor’s degree in Health Sciences, Communication Sciences and Disorders, Nursing or equivalent. Equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
- 2 - 3 years medical device clinical trial experience.
- Clinical research certification from ACRP or SOCRA strongly preferred.
- Broad understanding of applicable Good Clinical Practices (GCP), International Conference of Harmonization (ICH), Code of Federal regulations (CFR) and ISO14155.
- Experience with Electronic Data Capture (EDC) systems.
- 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).
- Travel is required up to 50%
Physical & Mental Demands
The physical and mental demands described below are representative of those that must be met to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the individual is regularly required to be in a stationary (seated/standing) position; utilize business technology for work product delivery, communicate orally and in writing with others internal or external to the organization, utilize problem solving/critical thinking skills to discern and convey information.
While performing the duties of this job, the individual is regularly required to utilize comprehension, critical thinking, communication, problem solving, organization reasoning, relating to others and discernment of items such as product specifications, procedures and processes to customers (whether internal or external). Influence, organization/classification of information and planning are also required.
The work environment is an office environment.
In addition to the opportunity to develop your knowledge and grow professionally, we offer competitive wages and benefits. The Target Salary Range for this position is: $75,000 - $90,000 annually as well as a bonus of 4% of your base salary.
The overall benefit program includes medical, dental, vision, life and disability, pet insurance, 401K Matching, PTO (vacation, holidays, floating holidays, sick and volunteer time off), tuition reimbursement, transportation supplementation, maternity and paternity leave, and wellness programs.
Apply now by completing your application form online. Applicants must meet the job specific application criteria to be considered. Visit our careers site at www.cochlear.us/careers to learn more.
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 303-264-2549.