Kelly Hardy

Under guidance of the Senior Medical Project Coordinator may perform the role of Global PVG Project Lead with any safety listing review, safety coding review and serve as primary point of contact for global functional groups, as applicable. Under guidance of the Senior Medical Project Coordinator responsible for or independently contributes to the generation of the Medical Management plan (MMP) and other study start up activities including assisting in risk assessment, audit preparation and readiness, facilitating meetings and oversight for all contracted PVG services. Familiar with budget and contracted services to assess ongoing costs and unit allowances. Will escalate any potential out of scope requests and services to the appropriate staff. Contributes to the financial oversight, staff and unit projections, invoicing, and initiate and manage contract modification/ change orders. Coordinate and supports the Medical Monitoring team with a preliminary safety review of laboratory data, diagnostic findings, clinical and coding listings. Ensure that client timelines are met with contracted Medical Management responsibilities. Collaborate with other intra-department functional leads in the efficient preparation and delivery of safety, coding, and safety data reviews using electronic methods.

Provided advanced level technical and medical information, and/or performs intake of complex adverse events/ product complaints with exceptional customer service. Expertly analyzed and researches inquiries and documents interactions according to organizational, client and regulatory guidelines. Assisted with training, quality checks and mentors staff. Functioned as subject matter expert (e.g., product champion) and has a lead role on behalf of management. Conducted training to new hires in the role of training liaison.

Provided technical and medical information and performed intake of adverse events/ product complaints with exceptional customer service. Analyzed and researched inquiries and documents interactions according to organizational, client and regulatory guidelines. Assisted with training, quality checks and mentored staff. Participated in face to face communications with clients on a regular basis along-side management. Conducted training to new hires in the role of training liaison.

Provided medical information with high quality customer service. Researched and responded to inquiries and documents appropriately according to PPD and client guidelines. Identified and recorded adverse events and product complaints. If needed, provided clinical trial information, after-hours on call support, as well as processed medical information requests via mail, fax, e-mail. Conducted training to new hires in the role of training liaison.

Practiced registered nursing on a medical-surgical unit. Developed and used critical thinking skills, prioritization, delegation, time management, and leadership skills. Performed accurate and focused assessments, computer documentation, medication administration, wound care, etc. according to company policy and guidelines. Frequent communication with Medical Doctors, medical staff and teams, and patients/families was conducted. Functioned as a preceptor to train new staff according to unit specific guidelines. Participated in role as charge nurse. Employed full time from June 2013-June 2014 and then employed on a PRN basis from June 2014-March 2019.

Practiced registered nursing on a post-operative ambulatory surgical unit. Developed and used critical thinking skills, prioritization, delegation, time management, and leadership skills. Performed accurate and focused assessments, computer documentation, medication administration, wound care according to company policy and guidelines. Frequent communication with Medical Doctors, medical staff and teams, and patients/families was conducted. Functioned as a preceptor to train new staff according to unit specific guidelines.