Clinical Research Scientist/Senior Clinical Research Scientist - San Diego, CA | Biospace
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Clinical Research Scientist/Senior Clinical Research Scientist

Alere

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Location:
San Diego, CA
Posted Date:
10/12/2016
Position Type:
Full time
Job Code:
08312
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:
Clinical Operations, Clinical Research, Clinical Scientist, Development, Research, Research Scientist,

Job Description


This position falls under the Alere Clinical Affairs organization .The Sr. Clinical Research Scientist is responsible for designing, preparing, and implementing clinical plans, strategies, protocols, analysis plans, study reports, and publications. The Sr. Clinical Research Scientist acts in an independent manner and requires a low degree of supervision. The successful candidate will need to physically reside at the San Diego site.

Major Functional Objectives:
•   Draft, review, and issue clinical study protocols and clinical study reports aimed at validating new products and product claims in support of regulatory submissions worldwide
•   Work with multidisciplinary teams to design, prepare, and implement clinical plans, strategies, protocols, analysis plans, study reports, and publications
•   Have the ability to understand, interpret and summarize the results of statistical analysis, and guide follow-up analysis for the Biostatistics group
In cooperation with Clinical Trial Managers and Data Management, develop case report forms that are compatible with the study protocol
•   Serve as a representative at scientific meetings and investigator meetings during which study designs/data are presented and reviewed
Provide clinical research expertise in support of all areas of Alere business interest
•   Ensure appropriate study design to demonstrate that product performance in a clinical setting meets or exceeds acceptance criteria
•   Accompany Regulatory Affairs personnel to FDA meetings as required
•   Search and review clinical literature for the evaluation of new products and product claims
•   Timely drafting of clinical study protocols and clinical study reports aimed at validating new products and product claims in support of regulatory submissions worldwide
•   Balance multiple projects and competing priorities to deliver quality work-product on time

Requirements


•   Ph.D., M.S., or graduate-level professional degree in a biological, biomedical, chemical, health sciences, or related fields
•   At least 3 years’ relevant in vitro diagnostics experience
•   Knowledge and experience with design controls, GCP, HIPAA, QSR, TITLE 21 CFR
•   Knowledge of clinical study design and execution
•   A strong record of accomplishment in research related to clinical science
•   Strong written and oral communication skills in multi-disciplinary environment
•   Microsoft Word, Excel, PowerPoint
•   Flexible, good natured, cordial team player
•   Excellent communications in multi-disciplinary environment
•   Fast-paced environment working with interdisciplinary teams
•   Compliance with company regulations