Brooke Ackerman Email and Phone Number

• Serve as central point of contact with investigator and staff, scientific field staff (as applicable), and sponsor counterparts with respect to assigned studies.• Track study progress from initial submission of concept through delivery of final manuscript• Collaborate with IIS Clinical Trial Assistant and other Local Trial Managers on accurately updating and maintaining key account IIS systems that track clinical supplies, study progress and milestones, serious adverse event… Show more • Serve as central point of contact with investigator and staff, scientific field staff (as applicable), and sponsor counterparts with respect to assigned studies.• Track study progress from initial submission of concept through delivery of final manuscript• Collaborate with IIS Clinical Trial Assistant and other Local Trial Managers on accurately updating and maintaining key account IIS systems that track clinical supplies, study progress and milestones, serious adverse event submission, payments and abstract and manuscript review.• Collaborate with IIS Local Trial Manager on the preparation, handling, distribution, filing, and archiving of IIS documentation and reports according to the work order and standard operating procedures. Assist with periodic review of study files for accuracy and completeness.• Collaborate with IIS Lead Local TrialManager on the distribution of Clinical Study Supplies and maintenance of tracking information.• Act as a central contact for the IIS team for designated project communications, correspondence and associated documentation.• Assist in training and orienting new staff. May act as a mentor for less experienced IIS Clinical Trial Assistants.• Attends and participates in customer Scientific Affairs Liaison team calls. • Maintains open dialog with Investigators during trials. • May perform assigned administrative tasks to support team members with IIS trial execution.• Serve as a mentor to other Local Trial Managers and Clinical Trial Associates Show less

• Serve as central point of contact on Quintiles team with investigator and staff, scientific field staff (as applicable), and sponsor counterparts with respect to assigned studies.• •Track study progress from initial submission of concept through delivery of final manuscript• Collaborate with IIS Clinical Trial Assistant and other Local Trial Managers on accurately updating and maintaining key account IIS systems that track clinical supplies, study progress and milestones, serious… Show more • Serve as central point of contact on Quintiles team with investigator and staff, scientific field staff (as applicable), and sponsor counterparts with respect to assigned studies.• •Track study progress from initial submission of concept through delivery of final manuscript• Collaborate with IIS Clinical Trial Assistant and other Local Trial Managers on accurately updating and maintaining key account IIS systems that track clinical supplies, study progress and milestones, serious adverse event submission, payments and abstract and manuscript review.• Collaborate with IIS Local Trial Manager on the preparation, handling, distribution, filing, and archiving of IIS documentation and reports according to the work order and standard operating procedures. Assist with periodic review of study files for accuracy and completeness.• Collaborate with IIS Lead Local TrialManager on the distribution of Clinical Study Supplies and maintenance of tracking information.• Act as a central contact for the IIS team for designated project communications, correspondence and associated documentation.• Assist in training and orienting new staff. May act as a mentor for less experienced IIS Clinical Trial Assistants.• Attends and participates in customer Scientific Affairs Liaison team calls. • Maintains open dialog with Investigators during trials. • May perform assigned administrative tasks to support team members with IIS trial execution.• Serve as a mentor to other Local Trial Managers and Clinical Trial Associates Show less

• Collaborate with Local Trial Manager on accurately updating and maintaining key account IIS systems that track clinical supplies, study progress and milestones, serious adverse event submission, payments and abstract and manuscript review.• Collaborate with Local Trial Manager on the preparation, handling, distribution, filing and archiving of IIS documentation and reports according to the work order and standard operating procedures. Assist with periodic review of study files for… Show more • Collaborate with Local Trial Manager on accurately updating and maintaining key account IIS systems that track clinical supplies, study progress and milestones, serious adverse event submission, payments and abstract and manuscript review.• Collaborate with Local Trial Manager on the preparation, handling, distribution, filing and archiving of IIS documentation and reports according to the work order and standard operating procedures. Assist with periodic review of study files for accuracy and completeness.• Collaborate with Local Trial Manager on the distribution of Clinical Study Supplies and maintenance of tracking information.• Act as a central contact for the IIS team for designated project communications, correspondence, and associated documentation.• Assist in training and orienting new staff. May act as a mentor for less experienced IIS Therapeutic Coordinators and Local Trial Managers.• May attend and participate in MAPPM meetings.• Maintains open dialog with Investigators during trials.• May perform assigned administrative tasks to support team members with IIS trial execution. Show less

• Collaborate with Local Trial Manager on accurately updating and maintaining key account IIS systems that track clinical supplies, study progress and milestones, serious adverse event submission, payments and abstract and manuscript review.• Collaborate with Local Trial Manager on the preparation, handling, distribution, filing and archiving of IIS documentation and reports according to the work order and standard operating procedures. Assist with periodic review of study files for… Show more • Collaborate with Local Trial Manager on accurately updating and maintaining key account IIS systems that track clinical supplies, study progress and milestones, serious adverse event submission, payments and abstract and manuscript review.• Collaborate with Local Trial Manager on the preparation, handling, distribution, filing and archiving of IIS documentation and reports according to the work order and standard operating procedures. Assist with periodic review of study files for accuracy and completeness.• Collaborate with Local Trial Manager on the distribution of Clinical Study Supplies and maintenance of tracking information.• Act as a central contact for the IIS team for designated project communications, correspondence, and associated documentation.• Assist in training and orienting new staff. May act as a mentor for less experienced IIS Therapeutic Coordinators and Local Trial Managers.• May attend and participate in MAPPM meetings.• Maintains open dialog with Investigators during trials.• May perform assigned administrative tasks to support team members with IIS trial execution. Show less

• Collaborate with IIS Program Manager on accurately updating and maintaining key account IIS systems that track clinical supplies, study progress and milestones, serious adverse event submission, payments and abstract and manuscript review.• Collaborate with IIS Program Manager on the preparation, handling, distribution, filing and archiving of IIS documentation and reports according to the work order and standard operating procedures. Assist with periodic review of study files for… Show more • Collaborate with IIS Program Manager on accurately updating and maintaining key account IIS systems that track clinical supplies, study progress and milestones, serious adverse event submission, payments and abstract and manuscript review.• Collaborate with IIS Program Manager on the preparation, handling, distribution, filing and archiving of IIS documentation and reports according to the work order and standard operating procedures. Assist with periodic review of study files for accuracy and completeness.• Collaborate with IIS Program Manager on the distribution of Clinical Study Supplies and maintenance of tracking information.• Act as a central contact for the IIS team for designated project communications, correspondence, and associated documentation.• Assist in training and orienting new staff. May act as a mentor for less experienced IIS Therapeutic Coordinators.• Attends and participates in customer Scientific Affairs Liaison team calls.• Maintains open dialog with Investigators during trials.• May perform assigned administrative tasks to support team members with IIS trial execution. Show less

• Perform clinical monitoring in compliance with FDA regulations and all related SOPs• Monitoring visits include evaluation, initiation, interim and• Close out visits• Coordinates collection of information from investigational sites• Completes trip reports and is responsible for all communication with sites

• Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.• Collaborate with CTL on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.• Assist with periodic review of study files for accuracy and completeness.• Collaborate with… Show more • Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.• Collaborate with CTL on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.• Assist with periodic review of study files for accuracy and completeness.• Collaborate with CTL on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.• Assist in training and orienting new staff. May act as a mentor for less experienced CTAs.• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required approval.• May perform assigned administrative tasks to support team members with clinical trial execution.. Show less

• Ensure that all documents received are scanned in to the Electronic Trial Master File According to PRA Filing Guidelines.• Provide feedback to Quality and Process Management regarding process inefficiencies and inconsistencies and suggestions for improvement.• Assign and monitor daily tasks to Document Management Associates.• Assist Manager to determine high priority projects.• Serve as a primary contact for 15 TMF Scanning Associates.

• Performed Quality Control steps to ensure that all paper Trial Master File folders are complete, reflective of the documents in the Electronic Trial Master File, and that their documents are filed correctly. These steps will keep the project Trial Master File audit-ready and will assure that the returned Trial Master File conforms to the client s Filing Guidelines.• Served as a host to clients, regulatory agencies, and Quality Assurance department during Client Audits. Liaises with… Show more • Performed Quality Control steps to ensure that all paper Trial Master File folders are complete, reflective of the documents in the Electronic Trial Master File, and that their documents are filed correctly. These steps will keep the project Trial Master File audit-ready and will assure that the returned Trial Master File conforms to the client s Filing Guidelines.• Served as a host to clients, regulatory agencies, and Quality Assurance department during Client Audits. Liaises with internal and external customers to meet project specific goals.• Served as a primary contact for 12 Quality Control Associates. Show less