SUMMARY:

• Senior Clinical Research Associate, has been in clinical research since December 2007. Ms. Kimmel has a strong background in clinical monitoring, with experience in all aspects of project phases from site selection to close - out, including both in-patient and out-patient studies.
• Ms. Kimmel has a strong background in both traditional monitoring and risk based monitoring. Ms. Kimmel has experience in Phase I-IV clinical trials, in national and international drug studies with emphasis on compliance with FDA regulations/GCP and ICH guidelines. Ms. Kimmel has experience with electronic data capture, electronic medical records, fax data capture and CTMS.
• Mrs. Kimmel has managed a team of 10-15 CRAs as well as being the contact person for sites to build site relationships. Prior to her management of CRAs, Ms. Kimmel supported both sites and CRAs through the mentoring capacity of their role to improve the experiences of the customers and the patients, as a Site Network Manager.

PROFESSIONAL EXPERIENCE:

Confidential

Contract Senior Clinical Research Associate

Responsibilities:

• Perform site selection visits in accordance with contracted scope of work, including risk based monitoring, and good clinical practice.
• Evaluate the quality and integrity of study site practices related to the expectations of proper conduct of the protocol and adherence to applicable regulations.
• Evaluate the site’s operating processes and confirm the processes will meet GCP expectations, should the site be selected.
• Tour the sites to confirm they meet the study specific expectations.
• Document if the site does or does not qualify to conduct the study.
• Collect all information and documents from site, to provide to the Sponsor, to confirm if site is suitable to conduct the study which is in the start up phase.

Confidential, Overland Park, KS

Senior Clinical Research Associate

Responsibilities:

• Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work, including risk based monitoring, and good clinical practice.
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
• Act as a mentor for clinical staff including conducting co-monitoring and training visits.
• Provide assistance to the CTL with design of study tools, documents and processes.

Confidential, Overland Park, KS

Associate Site and Resource Manager

Responsibilities:

• Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; gathering feedback for appraising performance, guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters in consultation with Human Resources and other relevant departments.
• Formulate strategies and action plans to maximize delivery of a high quality team/department monitoring service, ensuring achievement of individual/team/department targets, aligning with company strategies.
• Ensure sufficient level and profile of resource is recruited for each project. Maintain systems compliance and oversight for effective project delivery. Collaborate with the Clinical Lead/Project Lead to ensure that resource needs and site requirements are met.
• Drive and manage Quintiles key strategic site relationships in order to build capability, drive productivity and robust quality management in line with site strategy. Be an advocate for these sites within Quintiles.
• Manage, develop, coach, and motivate CRAs to develop their skills to ensure that a high professional standard is achieved and project targets are met. Be an advocate for individual career development.
• Conduct Accompanied Site Visits (ASV’s) to develop CRA’s skills (e.g. patient recruitment). Support CRA’s on solving project specific issues across site portfolio.
• Identify quality risks and issues and suggest appropriate corrective action plans to senior management to prevent or correct deficiencies in performance of employees.
• Share Quintiles and customer key business drivers with all CRA staff. Drive decision making in line with these.
• Attend customer meetings, maintain interactions with any local sponsor affiliates.
• Maximize profitability by ensuring project objectives and customer requirements are achieved
• Ensure that staff have the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan and mentored training experiences.
• Ensure timely and accurate reporting of required information on company systems.
• Support continuous improvement of monitoring processes to deliver quality, consistency and efficiency in delivery.
• Participate in the selection process for new staff by conducting candidate review and participating in the interviewing process. Conduct on-boarding training for new staff in conjunction with Human Resources and Learning and Development training programs.
• Project a professional impression of the Company and act in accordance with the relevant Pharmaceutical Industry’s Code of Practice
• Perform other duties as assigned.

Confidential, Overland Park, KS

Site Network Manager

Responsibilities:

• Ensure right sites are selected for assigned studies by collaborating with project strategy and project teams.
• Drive and own strategies for non-project issues such as site business strategy, infrastructure and capabilities, mutual recruitment pipelines, achieving patient recruitment and performance results for assigned sites.
• Focus and concentrates more projects into fewer sites through improved capabilities for enhanced recruitment performance.
• Own and optimize project delivery across portfolio of sites including linkage to the therapeutic requirements of the future (productivity, quality, thought expertise).
• Conduct Accompanied Site Visits (ASVs) to guide CRAs and advise on critical specific study issues. Support CRAs on resolving project specific issues across site portfolio.
• Support process improvement through working with Quintiles processes to deliver quality and consistency in assigned geographic territory. Evaluate, develop and regional site portfolio through regular on-site visits
• Mentor CRAs guiding professional development across assigned mentees.
• Collaborate in the selection and onboarding process for new CRA's by conducting candidate review and participating in the interviewing process. Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs.

Confidential, Overland Park, KS

Senior Clinical Research Associate

Responsibilities:

• Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
• Act as a mentor for clinical staff including conducting co-monitoring and training visits.
• Provide assistance to the CTL with design of study tools, documents and processes.

Confidential, Overland Park, KS

Senior Clinical Research Associate

Responsibilities:

• Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Escalate quality issues to the Project Manager.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
• Act as a mentor for clinical staff including conducting co-monitoring and training visits.

Confidential

Clinical Research Associate

Responsibilities:

• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
• Conduct monitoring at clinical trial site to ensure compliance with GCPs, study protocol, and SOPs including source document review and/or case report form data for integrity and consistency.
• Generate and resolve queries.
• Serve as contact with sites to provide support during the conduct of the clinical trial and serve as a resource for the clinical sites for protocol and procedural questions.
• Track and account for the review of all CRFs.
• Provide training to sites on study conduct, CRF completion and data management expectations.
• Prepare expense reports, visit reports and schedule subsequent visits within the confines of the study budget.
• Monitor available drug supply at sites.
• Prepare monitor plans.
• Develop and adapt monitoring tools.
• Participate in start-up study activities.
• Review in-house data.
• Mentor, train and conduct co-monitor visits with entry level CRAs.
• Assist in the identification of potential investigators and criteria to qualify the site.
• Assist Regulatory Affairs with submission of IND/NDA and IDE/510K.
• Provide input and recommendations to internal/external project team for protocol design.
• Provide input and recommendations to Product Management for drug development.
• Create Standard Operating Procedures for the Clinical Development group.
• Create a Trial Master File.

Confidential

Medical Research Associate

Responsibilities:

• Provide clinical/medical support to all departments (Research and Development, Sales, Marketing, Education/Training, and Customer Support) with regards to nosocomial infections, device-related infections, and modes and mechanisms of antiseptics.
• Provide training, in regards to the Clinical Compendium for company product.
• Create synopsis and provide training on published studies related to infection prevention.

Confidential

In-House Clinical Research Associate

Responsibilities:

• Conduct co-monitoring at clinical trial site to ensure compliance with GCPs, study protocol, and SOPs including source document review and/or case report form data for integrity and consistency.
• Track and account for the review of all CRFs for studies assigned.
• Review in-house data.
• Assist other departments within the organization as needed (e.g. Regulatory Affairs IND/NDA submission)