Clinical Research Scientist

The Opportunity

This position works out of our Sylmar, CA location in the CRM Cardiac Rhythm Management division.

As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

Provides scientific expertise throughout the development and implementation of clinical studies, clinical evaluations, or risk management. Writes / manages clinical trial protocols, protocol amendments, clinical study project timelines, clinical evaluations (planning and reports), risk master lists, clinical trial registrations and results postings, and scientific publications. Interacts with various study support groups and cross-functional teams in order to assist in clinical strategy, the development of study or clinical evaluation plans, and project or report deliverables. Interacts with regulatory agencies as needed, and will use their scientific and medical knowledge in order to provide directives to staff as well as study sites as appropriate.

As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

appropriateness.

WHAT YOU’LL DO

• Facilitates communication between Marketing, R&D, , Regulatory Affairs, Product Performance Group (PPG), Quality Engineering, Clinical Affairs or Clinical Science, Risk Management, Clinical Project Management, and internal/external CROs  for clinical studies and activities.

• Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.

• Participates in the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction.

• Writes study protocols, protocol amendments, informed consents, clinical evaluation plans and reports, risk master lists, and scientific abstracts/papers for publication by evaluating scientific literature and publications, analyzing scientific data and staying abreast of current clinical practice.

• Interprets Phase I, to IV clinical study results in preparation for new product applications by evaluating scientific literature and publications, analyzing scientific and risk data and staying abreast of current clinical practice.

• Presents scientific data by communicating accurate, succinct summaries of clinical study work at industry gatherings, investigational meetings and regulatory agency meetings.

• Provides accurate progress reports on clinical projects by writing assigned clinical portions of reports for submission to regulatory agencies, Institutional Review Boards, Medical Ethics Committees, etc.

• Participates in and supports audits.

• Working technical knowledge and application of concepts, practices and procedures. General understanding of business unit/group function. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.

EDUCATION AND EXPERIENCE YOU’LL BRING

• Bachelors Degree in biological or physical sciences, or mathematics

• 0-2 yrs. experience

• Awareness of experimental approaches/protocols and scientific methods such as designing experiments and interpreting data.

• Awareness of regulations and standards affecting IVDs and Biologics

• Basic Computer Skills

• Working technical knowledge and application of concepts, practices and procedures. General understanding of business unit/group function.

• Will perform this job in a  quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.

• Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.

• Exercises judgment within defined procedures and practices to determine appropriate action. Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.

Preferred Qualifications

• Clinical Trial/Research Experience

Apply Now

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