Jackie Fowler (Yow) Email & Phone Number

Wilmington, Nc, Us

Responsible for site management activities, planning, implementing and tracking of the clinical trial process, administration of clinical trials and maintaining an overview of assigned oncology trials.

Wilmington, North Carolina

Wilmington, North Carolina, United States

Associate Clinical Trial Manager with Seagen Inc.

Wilmington, North Carolina Area

•Accountable for impact, effectiveness and development of Standard Operating Procedures, training materials and work instructions to improve processes within the Clinical Operations department.•Management responsibilities include: hiring and onboarding CRAs, PTAs and interns, reviewing and approving timesheets and expense reports, managing learning management system compliance, conducting performance appraisals and guiding professional development, forecasting and assigning study… Show more •Accountable for impact, effectiveness and development of Standard Operating Procedures, training materials and work instructions to improve processes within the Clinical Operations department.•Management responsibilities include: hiring and onboarding CRAs, PTAs and interns, reviewing and approving timesheets and expense reports, managing learning management system compliance, conducting performance appraisals and guiding professional development, forecasting and assigning study assignments and ensuring workload is appropriate through regular one-on-one meetings. •Perform accompanied site visits to ensure CRAs are maintaining compliance with GCP, study protocol/plans and company SOPs. Report performance assessment feedback and provide mentoring to under performing associates. Coach developing CRAs through internal CRA training program by utilizing various training methods. •Identify and institute appropriate actions and procedures to effectively address internal CAPA findings. Create workflows to avoid reoccurring deviations by performing a gap analysis on current processes. •Implemented, validated and manage the company’s CTMS and eTMF from inception to final execution. Responsible for maintaining licenses, training new hires and creating processes that align with activities associated with the lifecycle of a study.•Lead the clinical systems vetting process to secure virtual trial solutions for the Clinical Operations department to operationalize virtual trials. Conducted internal validation testing by developing and executing test scripts. Developed new practices to utilize the remote monitoring approach efficiently and effectively for virtual trials. •Ensuring the department and staff have proper resources, tools, technology and training to aide in their dedicated job responsibilities. •Participated in the preparation and delivery of Bid Defense presentations. Worked in collaboration with business development and proposals to secure new business. Show less

Wilmington, North Carolina

Responsible for management of day to day aspects of investigator site and Clinical Research Associate/Project Team Associate activities for the assigned clinical trial(s). Accountable for the quality, timely, and cost effective completion of the Sponsor’s study in concert with the Project Manager. Conduct assigned study related clinical services and assist in the management of CRAs for either domestic or globally run clinical trials. Manage projects and assist quality assurance by performing… Show more Responsible for management of day to day aspects of investigator site and Clinical Research Associate/Project Team Associate activities for the assigned clinical trial(s). Accountable for the quality, timely, and cost effective completion of the Sponsor’s study in concert with the Project Manager. Conduct assigned study related clinical services and assist in the management of CRAs for either domestic or globally run clinical trials. Manage projects and assist quality assurance by performing quality control audits. Work with relevant project team members to prepare study forms and to provide tracking reports on enrollment, CRF submission, study start up and study completion information.Other tasks performed:- Implemented new CTMS system - SOP development - CRA Interviews - Training resources Show less

Wilmington, North Carolina

Monitor Phase II, III, IV clinical trials on the east coast. Conduct monitoring visits at assigned sites for protocols that are complex and/or require knowledge in advanced therapeutic areas. Ensure that clinical research studies are conducted in accordance with the protocol, stand operating procedures, good clinical practice, and applicable regulatory requirements.Disease experience: Schizophrenia, Lupus, BPH- nocturia, Alzheimer, Heart Failure and Diabetes.

Raleigh-Durham, North Carolina Area

Conduct monitoring visits at assigned sites for protocols that are complex and/or require knowledge in advanced therapeutic areas. Ensure that clinical research studies are conducted in accordance with the protocol, stand operating procedures, good clinical practice, and applicable regulatory requirements.

Raleigh-Durham, North Carolina Area

Wilmington, North Carolina Area

Wilmington, North Carolina Area

Wilmington, North Carolina Area

Wilmington, North Carolina Area

Provided personal care assistance to a total of 10-12 residents.Recorded any incidents and all input/output.Experienced at transferring, lifting, raising beds and transfer equipment.Provided regular checks on residents insuring comfort, safety and privacy.

Bachelor Of Science (B.S.), Clinical Research

Activities and Societies: Honor Society Member

Associate Of Arts (A.A.), Art/Art Studies, General

Activities and Societies: Presidents List (4.0 GPA) Merit Scholarship Recipient College Transfer - General studies completed 2014