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Clinical Trials Manager /Senior Clinical Research Associate

Virobay

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Location: Menlo Park, CA Posted Date: 4/15/2013 Position Type: Full time Job Code: Virobay-CL01 Required Education: Bachelors Degree Areas of Expertise Desired: Clinical Data Management
Clinical Research

Description

Virobay is a clinical-stage pharmaceutical company focused on the development of novel cathepsin inhibitors.  Our pipeline of both partnered and un-partnered compounds is expanding with an increase in the number of clinical trials.  Located in Menlo Park, we seek an experienced clinical trial manager/director to work with CROs and the internal project team to oversee trial design and execution.  Position will report directly to the CMO

The CTM/Sr. CRA performs and coordinates all aspects of the clinical monitoring process in our Clinical Development Department in accordance with GCP’s and global SOP’s to assess the safety and efficacy of investigational products.  Will conduct independent monitoring of sites to determine adherence to protocol, applying knowledge of FDA regulations to ensure regulatory compliance.  Assists the CMO, coordinating activities of the CRO and investigators.  In addition:

•   Assists with the development of clinical study protocols, informed consent forms and CRFs
•   Responsible for the review and finalization of project and study-related documents including:  contracts, budgets, safety reporting, IND Annual Updates and review of any clinical trial presentations and publications, as required
•   Assume responsibility for managing CRO trial related trial activities including CRF data management, ethics committee approvals, shipment of clinical trial materials, patient recruitment and timely execution of the clinical trials
•   Maintains contact with study sites for issues, resolution, and regulatory documentation
•   Ensure GCP compliance through provision of training at start-up and initiation meetings for clinical trials and on-going SOP development; assists with writing of clinical SOPs
•   Coordinate trial execution by managing CRO relationships, establishing appropriate audit procedures and ensuring that cleaned data is entered into the database in a timely fashion
•   Participate in drug product research teams ensuring that colleagues are updated on all relevant issues and provide clinical input into early pharmaceutical research
•   Maintains study tracking tools and status reports
•   Assists in the review of clinical safety reports form sites
•   Ensures appropriate documentation of all site and protocol related issues
•   Travel as required to fulfill project objectives

Requirements

The qualified candidate will possess:
•   5-7 years relevant pharmaceutical/biotechnology industry experience in clinical research/clinical operations and field monitoring
•   Bachelors degree in a scientific/clinical related discipline, RN or BSN degree/equivalent
•   Experience conducting qualification, initiation, interim and close-out visits
•   Good knowledge of FDA, GCP, GLP, and ICH guidelines/ regulations
•   Knowledge of the infrastructure and operational characteristics of CROs and centralized services
•   Regulatory Affairs/ FDA interaction experience a plus  
•   Good medical/ scientific written and verbal communication skills and investigative techniques
•   Strong problem solving skills, exceptional interpersonal skills with demonstrated successful team participation
•   Strong verbal, written, and presentation skills  
•   Understand the roles/responsibilities and inter-dependencies for key functions involved in study teams
•   Ability to interpret audit findings  
•   Excellent computer skills  
•   Familiarity with relevant study / program tracking systems
•   Willingness to travel (although primarily will work in a general office setting)
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