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Miles
Km80.5

Senior Clinical Research Associate

Raptor Pharmaceuticals

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Location: Novato, CA Posted Date: 4/19/2013 Position Type: Full time Job Code: SCRA Required Education: Bachelors Degree Areas of Expertise Desired: Biology
Pharmacology

Description

Summary Description
The Senior CRA is responsible for the implementation and management of assigned clinical studies, focusing on the areas of protocol development, study planning and conduct, site monitoring and/or monitoring management, enrollment and data quality, and adherence to corporate timelines and objectives.

Responsibilities
•Ensures that clinical documents (i.e. protocols, amendments, clinical study reports) and clinical sections of regulatory documents (i.e. IND annual reports, IND and NDA filings) are reviewed for consistency and quality.
•Leads the protocol development process.
•Responsible for the preparation of study documents, e.g. consent and assent templates, site reference materials, site monitoring plan, pharmacy manual.
•Prepares materials and provides training for study implementation, e.g. investigator meetings, vendor kickoff meetings, site initiation visits.
•Participates in assessment and selection of Contract Research Organizations (CROs), sites, and other vendors; may perform qualification visits as needed, solicit and review proposals, review or negotiate budget and Scope of Work.
•Responsible for oversight of CROs, sites and other vendors, ensures compliance with GCP/ICH, protocol, and Scope of Work;  initiates corrective and preventive action plans with as necessary;  performs site monitoring or co-monitoring visits.
•Manages Trial Master File and Clinical Trial Management System (CTMS); responsible for reconciliation of the TMF when transferred from an external vendor.
•Participates in preparation and training for FDA or other regulatory agency inspections, internal or external (i.e. investigational sites).
•May be responsible for the supervision and/or mentoring of regional or in-house clinical operations personnel.
•Assists in the review and development of Clinical Operations and other departmental SOPs.

Requirements

Requirements
•Bachelor’s degree in a biological science is preferred.  
•Requires a minimum of 3 years experience as a CRA, with orphan drug and/or rare disease knowledge very helpful.  
•Strong communication skills and ability to liaise with multiple regional and external colleagues is necessary.  
•Must be able and willing to travel on a periodic basis.

Please submit your resume and cover letter to careers@raptorpharma.com. Please also include the title of the position in the subject line of your email.

9 Commercial Blvd., Suite 200 - Novato, CA 94949
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