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Sr. Clinical/Clinical Scientist

Dart NeuroScience LLC

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Location:
San Diego, CA
Posted Date:
12/15/2014
Position Type:
Full time
Job Code:
14-032/14-033 #0151
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:

Job Description

DNS is seeking a motivated research professional to participate in all aspects of planning, implementing, managing and reporting of clinical studies, under the supervision of the department director, or designee.  This individual will provide key overall scientific and/or logistical support to clinical development programs in general.  

•   Assist in or design, author and/or review clinical study synopses, protocols, amendments, study reports and other study-related documents
•   Prepare clinical sections of registration documents (e.g., INDs, IND annual reports); provide input on preparation of other key clinical documents, e.g.:   Investigator’s Brochures, CRFs, Informed Consent forms, Statistical Analysis Plans, Data Management edit check specs, clinical supplies package diagrams and labeling
•   Assist in database finalization, review of study results and results interpretation
•   In collaboration with other team members (e.g., Clinical Operations, Data Management), assist in monitoring clinical trial conduct/status
•   Assist in identifying/evaluating vendors
•   Assist in planning and conduct of investigator meetings
•   Assist with fielding site questions during conduct of trials as needed

Requirements

•   5+ yrs clinical research scientist experience (other relevant research experience in the pharmaceutical industry may be considered)
•   Bachelors level degree required (Graduate level degree preferred) in a scientific discipline (Clinical Pharmacy, Nursing, Neuroscience, or Cognitive Science training a plus) Phase I-IIb clinical trial experience preferred
•   Thorough working knowledge/understanding of clinical trial design, methodology and statistical concepts
•   Working knowledge of the IND/NDA process
•   In depth knowledge of GCP/ICH guidelines
•   Experience in CNS-related  research highly preferred
•   Strong written and verbal communication skills as well as proven ability to interact with different functional groups
•   Good organizational, time management and interpersonal skills, proficiency in computer and software skills

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