To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #02587

About our client Our client is a rapidly growing global CRO headquartered on the east coast. The company has managed close to 150 protocols, boasts a deep network of over 3000 sites and has developed unparalleled expertise in cardiology and device studies. With strong financials, an experienced management team and loyal customer base, this is a strong opportunity for someone that wants to put their drive and initiative to work! Position Location Clinical Research Associate Midwest, USA Salary Highly competitive package, commensurate with experience Responsibilities 1) Develop a detailed working knowledge of all assigned protocols 2) Attend project-specific training as required 3) Manage sites according to project-specific Monitoring Guidelines and instructions from the Lead CRA 4) Schedule monitoring visits with all sites as required for the project and as outlined by the Lead CRA, while working within budgetary guidelines 5) Communicate expectations for and results from the monitoring visits with site personnel, the in-house project team and the sponsor 6) Write visit reports in the timeframe required by the project 7) Review available in-house data relating to recruitment and CRF status, as well as preliminary data from fax data systems or remote data entry systems, prior to visiting the site for each monitoring visit 8) Ensure that study recruitment goals and completion timelines are met and make suggestions to improve enrollment if necessary 9) Review source documents and Case Report Forms (CRFs) for each subject in accordance with country-specific regulations, ICH-GCP guidelines and company SOPs to ensure timely, accurate and quality data retrieval 10) Maintain internal and external study files and ensure that regulatory and other documents are complete and accurate in accordance with all requirements 11) Support administrative duties necessary for in-house, study site and data management operations, under the supervision of the Clinical Team 12) Assist the Project Manager with study management 13) Collect complete and monitored CRFs, and forward them to the Document Control 14) Document the collected forms 15) Facilitate the timely resolution of queries, either in-house or at the site (as required) 16) Track any outstanding queries to ensure that the process is complete and timelines are met 17) Maintain Inventory, retrieve clinical supplies and monitor disposition records 18) Participate in the training and mentoring of new CRAs, as requested 19) Attend pertinent classes, seminars and other training to maintain a high level of expertise in monitoring and in cardiovascular interventions and treatments 20) Complete time reports, expense reports and other administrative activities as required Requirements 1) Bachelor’s degree 2) 2 years of experience in clinical research 3) Experience in cardio-drug and cardio-device preferred 4) Ability to interact effectively with sponsors and other Project Team members 5) Ability to work in a matrix environment 6) Good communication (oral and written) skills