Clinical Trial Administrator
As the Clinical Trial Administrator, you will be responsible for the preparation and tracking of the clinical related documents/materials, assisting in the development of tools to conduct clinical studies. You will also be responsible to generate and review regulatory documents as required for each study. Simply stated, you will be the hub of the department.An Average Day
1. Assist with the coordination of site qualification, identification, and initiation processes along with critical study team members.
2. Manage Trial Master Files (TMF) and aiding team with reconciliation.
3. Manage and maintaining investigational supplies both on and off-site.
4. Aid in vendor management/support as necessary.
5. May assist in clinical monitoring of local field sites.
6. Contribute to study concept documents, protocols, clinical study reports, etc. under supervision.
7. Serve as a study contact during trial conduct including qualification, initiation, and maintenance phases.
8. Provide management with routine updates regarding the status of regulatory documents or other reports as deemed necessary.
9. May assist in the planning, management and reporting of clinical studies through oversight of cross-functional study activities, identification and resolution or escalation of issues, and communication of study timelines/deliverable.
10. Assist the study team in collection, tracking and reporting established KPIs such as query resolution, AE/SAE data collection, device reconciliation/shipment, site and patient enrollment, etc.
11. Preparation and distribution of minutes for departmental meetings
12. Submit clinical department documents to internal document control system and track approval of document
13. Construct case report form (CRF) binders and regulatory binders
14. Create and maintain multiple Excel databases
15. Perform highly accurate data entry within requested timelines
16. File and maintain clinical study documentation, including Case Report Forms and other study documentation
17. Set up Network Folder Structure for new clinical studies
18. Organize, categorize, and track electronic files
19. Maintain study photo archives and photo tracking system
20. Manage IRB communications and submissions including initial study and site submissions, study amendments, and annual reports and renewals
Must Have
1. Associates degree or equivalent experience in clinical administration
2. Familiar with good clinical practices, regulations, and standard operating procedures
3. Ability to travel locally as studies demand
4. Excellent interpersonal and organizational skills and strong attention to detail
5. Highly efficient, fast learner, self-motivated, able to follow specific directions, and able to maintain high quality of work in fast-paced environment
6. Computer literacy, proficiency in MS Office
Extra Awesome
1. Familiarity with medical terminology and clinical monitoring process
2. 2-4 years clinical administration experience within the medical device/pharma industry
3. BS/BA
4. Project management skillsEstimated Salary: $20 to $28 per hour based on qualifications.
1. Assist with the coordination of site qualification, identification, and initiation processes along with critical study team members.
2. Manage Trial Master Files (TMF) and aiding team with reconciliation.
3. Manage and maintaining investigational supplies both on and off-site.
4. Aid in vendor management/support as necessary.
5. May assist in clinical monitoring of local field sites.
6. Contribute to study concept documents, protocols, clinical study reports, etc. under supervision.
7. Serve as a study contact during trial conduct including qualification, initiation, and maintenance phases.
8. Provide management with routine updates regarding the status of regulatory documents or other reports as deemed necessary.
9. May assist in the planning, management and reporting of clinical studies through oversight of cross-functional study activities, identification and resolution or escalation of issues, and communication of study timelines/deliverable.
10. Assist the study team in collection, tracking and reporting established KPIs such as query resolution, AE/SAE data collection, device reconciliation/shipment, site and patient enrollment, etc.
11. Preparation and distribution of minutes for departmental meetings
12. Submit clinical department documents to internal document control system and track approval of document
13. Construct case report form (CRF) binders and regulatory binders
14. Create and maintain multiple Excel databases
15. Perform highly accurate data entry within requested timelines
16. File and maintain clinical study documentation, including Case Report Forms and other study documentation
17. Set up Network Folder Structure for new clinical studies
18. Organize, categorize, and track electronic files
19. Maintain study photo archives and photo tracking system
20. Manage IRB communications and submissions including initial study and site submissions, study amendments, and annual reports and renewals
Must Have
1. Associates degree or equivalent experience in clinical administration
2. Familiar with good clinical practices, regulations, and standard operating procedures
3. Ability to travel locally as studies demand
4. Excellent interpersonal and organizational skills and strong attention to detail
5. Highly efficient, fast learner, self-motivated, able to follow specific directions, and able to maintain high quality of work in fast-paced environment
6. Computer literacy, proficiency in MS Office
Extra Awesome
1. Familiarity with medical terminology and clinical monitoring process
2. 2-4 years clinical administration experience within the medical device/pharma industry
3. BS/BA
4. Project management skillsEstimated Salary: $20 to $28 per hour based on qualifications.
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