Carl Zeiss Meditec, Inc. is the worldwide leader in ophthalmic instrumentation. Our products are designed to advance the standard of eye-care worldwide.

By protecting one of our most precious senses -- sight, our employees contribute to the quality of life. We pride ourselves in fostering creative thinking and innovative ideas in a team-building environment. If you are passionate about making a difference in the lives of others and are interested in cultivating your talents in a challenging and rewarding environment, Carl Zeiss Meditec, Inc. may offer you the ideal career opportunity.

We currently have an exciting position in our Dublin, California Headquarters for a Clinical Research Associate.

JOB SUMMARY:

The Clinical Research Associate is responsible for supporting in-house testing of R&D prototype instruments.  The Clinical Research Associate may also assist with training external clinical study sites on the use of prototype and commercially available instrumentation.  The Clinical Research Associate may assist with the planning and execution of beta studies, including preparation of beta plans, beta protocols, and final beta reports.  The Clinical Research Associate may participate as a member of Project Teams, as assigned, representing the Clinical/Regulatory Affairs department.

ESSENTIAL FUNCTIONS:

·         Manage in-house testing of R&D prototype instruments, including recruitment of subjects, maintenance of the study log, and status reports. 

·         Work collaboratively with R&D, Clinical Affairs, and Marketing to support beta test activities, including the drafting of beta plans, beta protocols, and beta final reports.

·         Assist Clinical Affairs in drafting clinical procedures and protocols to ensure that clinical studies are completed professionally and in a timely manner. Assure that accurate records are maintained and provide periodic reports, where appropriate.

·         Assist with training of clinical investigators to ensure appropriate operation of instrumentation.

·         Represent CA/RA Department on Project Teams, where appropriate.

·         Conduct clinical site audits as necessary to support clinical studies.

·         Conduct clinical studies in a manner that ensures compliance with company’s SOPs, Institutional Review Board oversight, and following clinical practices. 

·         Perform others duties, as assigned.

Note: Essential functions may not be limited to the tasks and responsibilities listed within this section. Ordering of essential functions does not necessarily reflect importance of item.

WORKING RELATIONSHIPS:

The Clinical Research Associate reports directly to the Manager, Clinical Affairs.

FINANCIAL IMPACT:

Analysis prior to decision-making is necessary. Erroneous decisions will have an impact on the overall success of company operations and may delay achievement of business objectives.

WORKING ENVIRONMENT:

Work space – noise level low to moderate.

REQUIREMENTS:

·         Bachelor’s degree in an appropriate discipline or equivalent.  Work experience may be considered in lieu of Bachelor’s degree.

·         Must have excellent communication skills, both written and oral, and must be computer literate.

SPECIAL DEMANDS:

This position may require travel both within the U.S. and internationally.

Carl Zeiss Meditec, Inc. is an Equal Opportunity Employer (EOE) and strongly supports diversity in our workplace.

To Apply, please forward resumes to d.jobs@meditec.zeiss.com  

and reference # CZMIR08194-CS