Company DescriptionCareDx Inc. based in Brisbane California is a molecular diagnostics company focused on the discovery development and commercialization of high value non invasive tests to enhance the care and long term outcomes of transplant recipients. The company has commercialized AlloMap Gene Expression Profile Testing which aids physicians in surveillance of heart transplant recipients. New data was recently presented at ISHLT 2014 that further supports the clinical utility of AlloMap. CareDx Inc. also develops new tests for other solid organ transplantation which are in development.Job Description This position provides CRA support to clinical study teams. Monitor clinical trials to ensure trials are conducted per protocol and according to GCP and company SOPs and regulatory requirements.Specific responsibilities include but are ant limited to Conduct site selection and study site initiation visits. Conduct site training and monitoring for adherence to protocol requirements. Collect and process necessary documents with internal and external stakeholders for submission to institutions as required for study approval e.g. contracts and budgets consent forms support of documents required for IRB submissions. Process documents related to payments e.g. investigator payments for rendered services. Track enrollment and compliance to all necessary activities related to study follow up visits and take corrective actions as necessary to meet study performance and quality objectives. Ensure supplies for study sites are available. In association with the medical monitors recognize and report any hotspots or trends in clinical events occurring in the study Coordinate with Medical Monitoring team to track protocol violationsdeviations. Maintain study trackers Carries out operational plans including study site selection training ongoing monitoring including and management of clinical supplies and invoices for services. Contributes to the development and management of the study timelines resources budget risk and quality plans ensures accurate tracking and reporting of study metrics. Communication Act as a liaison between our company and clinical sites. Generate clear and concise trip reports site contact documentation monthly status reports e.g. enrollment adverse events budget etc. and as required clinical summaries. Maintain study documentation e.g. correspondence CRFs deviations budget information Regulatory Monitor activities at clinical study sites to ensure compliance with Good Clinical Practices GCPs IDE SOPs and study protocols. Assist in generation of protocols CRFs Informed Consent documents Instructions for Use Manuals and site training materials for pre and post market studies. Interaction with Clinical SitesInteract directly with clinical sites including clinical investigators and other health care professionals involved in the clinical study and maintain a positive rapport with each site. Conduct site visits e.g. site selection visits pre study site visits training visits site initiation visits interim site visits and study close out visits as required. Support sites in study conduct e.g. provide guidance on case report form CRF completion. Study Administration Manage product inventories for clinical studies. Ensure clinical studies are conducted in a timely manner and within site budgets. QualificationsAt Minimum Degreecertification in life sciences health sciences or equivalent degreeexperience e.g. BS RN RT Experience with clinical studies and data collection Ability to travel 50 75 in support of the primary clinical activities Knowledge of ICH GCP. Experience in working as part of a study team. Effective written and verbal communication skills. SpecificationsTitleClinical OperationsResearch Associate II ManagerClinical Operations Associate Director Location Brisbane CA Mid west Chicago Southeast Florida or Southwest Texas Additional InformationBenefits amp Perks We provide Medical Dental Vision and Life Insurance Flexible Spending and Dependent Care Accounts Commuter Accounts 401k 3 weeks of vacation 5 days sick leave 1 personal floating holiday 9 paid holidays gym reimbursement yoga onsite ping pong foosball BBQs social hours and more Sorry this job has expired