Scientist, Clinical Research

The Opportunity

We are seeking an experienced, high caliber Clinical Research Scientist in Sylmar, CA who 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.

Job Duties:

• Facilitates communication between Sales and Marketing, R&D, Clinical R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs or Clinical Science, Risk Management, Clinical Project Management, external CROs or Medical Writers, Training, and/or Senior Management and investigational sites as directed by your manager.
• Conducts team meetings, drafting and sending routine correspondence (e.g., newsletters) and by presenting regular updates to senior staff.
• Participates in site selection process by conducting meetings with appropriate departments and individuals to review and revise draft site list as necessary, and by communicating the final site list to team members.
• Creates, manages, or participates in clinical study or clinical evaluation timelines, and budgets by utilizing the appropriate project management tools, selecting providers, managing vendor contracts as requested, and ensuring expenditures are within budgetary guidelines.
• Allocates resources by utilizing the appropriate project management tools.; 5. 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 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.

Qualifications:

Education:

• Bachelors Degree (± 16 years) In related field or an equivalent combination of education and work experience

Experience/Background

• Minimum 8 years Related work experience with a complete understanding of specified functional area.
• Comprehensive knowledge of a particular technological field.
• Uses in-depth knowledge of business unit functions and cross group dependencies/ relationships.
• Is recognized as an expert in work group and across functions.
• Will perform this job in a quality system environment.
• Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• Has broad knowledge of various technical alternatives and their potential impact on the business.

*