Holly Rollins Email & Phone Number

Morrisville, Nc, Us

Morrisville, Nc, Us

Morrisville, Nc, Us

Morrisville, Nc, Us

• Executes and maintains communication and documentation for clinical studies in compliance with applicable local regulatory requirements and ICH guidelines. o Maintain study communication tools including web-based study applicationso Provides regular clinical status information to team members and project management and drafts study documentso Works closely with other team members to ensure timely resolution of project and/or clinical issues o Serves as remote site contact for all study-related issueso Coordinates shipping and tracking with all phases of the clinical studies• Performs regulatory file reconciliation and maintains central files; requests any new or updated essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements• Performs in-house monitoring tasks, including:o Data-cleaningo Writing and resolving data querieso Conducting routine TMF auditso Management of subject closeouto Develops study documentso Provides status reports• Prepares agendas and meeting minutes for internal and external team meetings• Investigator payments as needed• Site feasibility and investigator selectiono Assists with contract and budget negotiations during study start-upo Reviews and prepares IRB submissions materials o Assists with organization of investigator meetings and trainings as applicableo Serves as main contact during study start-up and site selection• Mentors and trains lower level In-House CRAs and Clinical Trial assistants on company-wide systems and procedures, as well as study-specific procedures.

Dublin, Coolock, Ie

• Management of a variety of sites participating in a long-term clinical device study, including assistance with study site start-up: completion of investigator agreements, regulatory submissions to sponsor and IRB and training on study protocol and procedures• Worked with sites on to ensure study-site compliance, including maintenance of accurate study records, high-levels of patient compliance and meeting study and FDA-given deadlines• Coordinator for various deadlines and projects including: o Queries: Lead for query resolution and data clean-up for bi-annual data locks and submission of safety data to the FDA. o Patient enrollment: Provided weekly reports regarding patient enrollmento Device accountability: Provided weekly reports of outstanding devices for reconciliation via device return, or form completion and receipto Incentive Payments: Provided weekly report of incentives to be paid for patients and investigators. Approved all site and patient payments and provided weekly totals to project leado Lead trainer for all new team members• Was chosen as a core team member for creation and implementation of new a new clinical trial management system and a new device accountability system. Duties included:o Testing accuracy of data transfero Creating and testing of new reportso Training study teams for both new systemso Point person for training new team members and other departments as well as first point of contact for questions or concerns regarding functionality of both systems• Member of a report sub-team focused on increased usability and efficiency with new CTMS, including new reports and system upgrades• Contributed to several department-wide projects to increase efficiency, including re-writing of SOPs and work instructions and implementation of new business practices• Extensive training on good clinical practices and monitoring both in-house and on site