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| Job #03663 |
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| About our client |
| Our client is a CRO based in California. They focus on providing services in data management, statistical analysis and study management. |
| Position |
Location |
| Senior Clinical Project Coordinator |
California |
| Salary |
| Highly competitive package, commensurate with experience |
| Responsibilities |
1) Lead all administrative and data management aspects of projects for multiple clinical trials 2) Work with minimal instruction and be able to set his/her own priorities as well as lead a team of clinical project coordinators, data coordinators and associate clinical data coordinators 3) Ensure all data management procedures are executed with a high attention to detail, accuracy and timeliness 4) Work on a multi-functional team, ask questions/answer questions about data received, interact with clients and maintain project-level perspective on data management issues, activities and deliverables 5) Develop, review and maintain a clinical database 6) Write and review a data management data quality plan 7) Update data and generate and review reports and listings 8) Write and review data entry and CRF instructions 9) Perform all aspects of the data management process as it relates to processing and QC of the data 10) Execute a variety of administrative tasks, including, but not limited to filing, printing, shipping and formatting deliverables 11) Assist in quality control of tracking, scanning and database audits 12) Participate in client communication 13) Respond to operations and data entry requests 14) Clean data for study close out and perform all database lock procedures 15) Coordinate the activities of project coordinators, data coordinators, associate clinical data coordinator and administrative support 16) Ensure all tasks are appropriately delegated, project milestones are met according to timelines and quality of work is maintained throughout 17) Attend all client calls for all team projects along with the Team Manager 18) Perform primary or secondary review for all study documents 19) Monitor study status updates on the Intranet 20) Assist in pre-database lock data review
21) Work as back-up for the Team Manager when the Manager is absent 22) Act as Assist Manager in leading weekly team meetings 23) Attend weekly team and monthly data management meetings. 24) Perform the tasks properly, efficiently and in accordance with client and company standards for timeliness and quality 25) Work on data entry and processing 26) Manage administrative tasks
27) Demonstrate knowledge of the drug development process and clinical trials 28) Ensure accurate and timely entry estimates and study status updates 29) Demonstrate computer literacy when executing routine computer-based tasks
30) Develop and maintain good client relationships and treat clients with a
respectful and positive attitude 31) Demonstrate comprehension of medical terminology 32) Monitor all study activities 33) Coordinate other team members (ACDC, CDC and/or CPC I/II) 34) Delegate tasks appropriately and with questions and direction 35) Communicate any issues or concerns to his/her manager proactively or as soon as they arise and in a professional manner 36) Share knowledge and resources with co-workers willingly 37) Attend weekly team meetings and monthly coordinator meetings 38) Emphasize the fundamentals of client focus 39) Generate a favorable climate for change, empower the group to use creative and innovative solutions to problems |
| Requirements |
1) Bachelor’s degree or higher, or equivalent experience 2) Minimum 2 – 4 years of relevant clinical research experience or relevant education 3) Experience in clinical data management systems and processes 4) Proficiency in Microsoft Office 5) Excellent organizational and time-management skills 6) Excellent verbal and written communication skills 7) Strong leadership skills 8) Ability to accept and apply constructive feedback 9) Ability to execute routine computer-based tasks 10) Strong attention to detail |

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