Clinical Research Associate, Senior

Advanced Clinical Services LLC is seeking a Senior Clinical Research Associate to assume a one year consulting position.  Located in San Francisco's North Bay, our client develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. This position offers a competitive salary and the opportunity for career growth.

In this role, the Senior Clinical Research Associate will participate in the development of study protocols, planning, implementation, CRO management and reporting, and the overall conduct and monitoring of the clinical study. This position will entail:  Establishing and maintaining the clinical study timeline Managing the coordination, preparation, and compilation of materials for clinical study conduct including model informed consent forms; study manuals, CRFs, clinical monitoring plan, data audit worksheet, clinical monitor safety evaluation guidelines, budget worksheet, subject status tracking and reference information Managing the current product inventory throughout clinical study (retention samples for QA; laboratory studies product; clinical study product).  Revising the clinical product inventory needs as indicated and communicating the revision to the Clinical Project Team. Ensuring compliance with protocol, regulatory, and overall clinical objectives Participating in the selection and management of CROs or other study vendors Overseeing and participating in the planning and execution of Investigator Meetings Validating the qualifications of investigators, medical centers, and investigational sites throughout the conduct of the study Creating and maintaining the monitoring plan throughout the study Independently monitoring the clinical study sites and documenting all findings, outcomes, and agreements reached during site visits Tracking the day-to-day progress of the clinical site activities  Updating the clinical study subject status at regular intervals  Creating clinical study metrics and other management tools Periodically reviewing adverse events reported in the study for identification and evaluation of safety issues and any patterns that are identifiable and reported to Medical and Regulatory Affairs  Managing the data discrepancies for the entire study or for assigned clinical study sites and coordinating the clinical monitoring activities to ensure that these discrepancies are resolved Overseeing the clinical operations activities conducted by more junior clinical operations staff Representing the company at clinical sites and at external project meetings as required

Education:B.S. degree, preferably in a Scientific field

Qualifications:5+ years experience in a Clinical Research Associate role with increasing responsibilities in study management Demonstrated experience in managing multiple sites as a Clinical Research AssociateKnowledgeable in Good Clinical Practice requirements and their application to the conduct of clinical studies in the United States Ability to learn and apply foreign regulations to the clinical trial / research processAbility to exercise discretion and independent judgment in the performance of required responsibilities Ability to work under only general supervision, working along technical lines requiring special training, experience, and knowledge Excellent verbal and written communication skills Excellent organizational skills Ability to travel is required

About Advanced Clinical Services LLC:

Since 1994 Advanced Clinical Services LLC has been an integral member of the clinical research community, providing national staffing services that unite clinical trial sponsors and CROs with experienced professionals. As an Advanced Clinical Services candidate, you will receive personal service from staffing professionals focused exclusively in the area of clinical research. We use our clinical research expertise, knowledge, pipeline, and strong industry relationships to provide you with matched opportunities. Our corporate headquarters is located in Downers Grove, IL and we have an office in San Francisco, CA.

EOE/AA M/F/D/V

We invite you to visit our Web Page at: http://www.advancedclinical.com