Labcorp Drug Development

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 Project Managers, Clinical Leads, and/or resource manager. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form completions and submissions and data query generation and resolution.  Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visits, reports, generating follow up letters and other required study documentation. May provide assistance to less experience clinical staff.

Also, I have shared some of the task of a clinical trials associate by leading meetings with Sponsor and Investigators. I currently work on a study that I have assisted with the onboarding of new Project managers and providing support to their role.

Experienced Senior Clinical Research Associate with a demonstrated history of working in the hospital & health care industry. Strong research professional skilled in Clinical Trial Site Management, ELectronic Medical Records, Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), Oncology, CRO Management, and Clinical Trials (Phase I through IV).

Senior CRA I

IQVIA

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 Project Managers, Clinical Leads, and/or resource manager. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form completions and submissions and data query generation and resolution.  Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visits, reports, generating follow up letters and other required study documentation. May provide assistance to less experience clinical staff.

Cra 2

Forsyth Medical Center

Clinical Research Coordinator

I am currently serving as primary site monitor with experience encompassing all on-site monitoring activities. I am currently a Senior CRA I working in phase I oncology. I am seeking to advance to a CTL or Project management role. I have been a CRA for 6 years and looking for the next opportunity in Clinical Research. Prior experience as a Oncology Study Coordinator for 6 years for industry sponsored Phase II-IV clinical research trials, including all study coordinator functions as well as site business management and contract/budget negotiations.

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