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| Job #02945 |
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| About our client |
| Our client is a well-known and highly reputable division of a leading academic research organization that is focused on developing therapeutics for significant unmet patient needs in the areas of endocrinology and metabolism. They boast an exceptional leadership team, diverse culture and have won numerous grants from the National Institutes of Health. This is a strong opportunity for someone that wants to put their drive and initiative to work! |
| Position |
Location |
| Senior Clinical Research Manager |
Chicago, Illinois |
| Salary |
| Highly competitive package, commensurate with experience |
| Responsibilities |
1) Manage clinical research programs including
supervision and evaluation of 2 – 5 research study coordinators, clinical
research associates, temporary employees as well as other staff 2) Ensure compliance with all SOPs for clinical research programs 3) Oversee the updating of documents and the development of new SOPs 4) Communicate clinical research plans/procedures to program members 5) Ensure staff members receive appropriate as well as updated training 6) Schedule and approve staff vacation/time-off requests, to ensure adequate program staffing is maintained 7) Conduct staff evaluations, performance reviews and performance improvement (as needed) 8) Create and maintain SOPs for program activities 9) Rotate pager coverage with other program staff members 10) Ensure telephonic, voicemail and e-mail accounts used for study subject communication maintain a uniform password 11) Compile and prepare study-subject data for publication 12) Work with research administrators providing information for proposals/reports 13) Assist Program Statistician on study-subject database updates and reporting 14) Ensure study protocols are maintained and adhered to by all staff members 15) Manage study subject recruitment and process flow 16) Provide interim status reports on clinical study progress 17) Liaise with Clinical Research Unit for all study-related issues 18) Prepare and maintain all regulatory (IRB and FDA) paperwork 19) Execute study subject history and physicals 20) Perform research studies (as needed) 21) Obtain samples and administer procedures based on study protocols 22) Oversee study subject scheduling and coordination of clinical care
23) Report and attend to any adverse events with study subjects
24) Serve as the point of contact for any study subject questions/concerns |
| Requirements |
1) RN/MS/comparable advanced degree 2) Minimum 3 years of clinical research experience (academic, research or hospital environment preferred) 3) Data management experience 4) Site monitoring and/or nursing experience preferred 5) Recent experience in managing/supervising clinical research coordinators 6) Knowledge of regulatory requirements for clinical research, including, IRBs and FDA INDs 7) Excellent writing, communication and computer skills 8) Familiarity with standard Microsoft Office software, including Excel |

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