Women’s Health - Pediatric Neurology-Neurology-Opthamology

Currently working as monitor for investigative sites across the U.S. Serving as the primary contact with individual investigative sites that conduct clinical research. Track study-specific status reports to ensure all required information regarding site issues, and deviations. Provide direct support to the Clinical Team Manager by assisting with monitoring visit report review and other managerial tasks. Perform study-specific training with project team. Perform Serious Adverse Event reconciliation. Review outstanding data reports and work with sites to ensure data collection is met per contractual guidelines. Assist sponsor, study sites, and CRAs with audit preparation/responses and quality issues. Develop collaborative relationships with investigative sites and client company personnel. Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices. Independently schedule and perform selection, initiation, interim, and close out monitoring visits and prepare required documentation. Review protocol violations with investigators and implements corrective actions to ensure future compliance the protocol and applicable regulations (FDA/GCP/ICH/IRB). Ensure that each investigator understands his/her obligations in regards to signing the FDA 1572, Good Clinical Practices, FDA regulations governing the use of investigational products, details of the protocol and the CRFs and overall objectives and expectations with respect to their participation in the clinical trial. Monitor investigational product accountability through physical inventory and records review. Ensure that any serious protocol or site issues are escalated in accordance with the monitoring plan/established study procedures.

Conducts all types of clinical monitoring visits (i.e., pre-study, initiation, interim and close-out) which includes all preparatory and follow-up aspects. Verifies proper administration of informed consent process at clinical sites. Confirms proper drug accountability and administration at clinical sites. Reviews and queries data on Case Report Forms and source documents. Adheres to monitoring plan and maintains site regulatory binder, and other site-specific and monitoring tools. Verifies appropriate reporting and documentation of adverse events, protocol deviations and subject enrollment.

Overseeing the progress and conduct of clinical trials at a research site (research center, clinic or physician's office). Participate in study initiation, progress, and conduct of the clinical trial to ensure the scientific integrity of the data collected, and the protection of the rights, safety, and well-being of human study subjects. Indications: Seasonal Allergic Rhinitis, VVA, Atopic Dermatitis and Psoriasis.

Supervised and trained a staff of one full-time employee and 20 volunteers. Aligned a productive budget of $25K+. Counseled families and students within the community. Developed, organized and taught a young women’s education program, ages 14-19. Coached students through life crisis. Created program guides. Conducted and documented follow-up with all program participants. Solely organized community events and youth camping experiences.

Assisted pathologist in the hospital with collection and preparation of specimens applying Good Laboratory Practices (GLP). Completed hospital policies training. Ensured appropriate labeling and storage. Entered data into sample data base system and filed reports. Maintained departmental records.

Completed HIPPA training. Reviewed pharmacy policy manuals. Identified prescription errors and fraudulent submissions. Verified patient identity. Using a computerized prescription management system, under pharmacist supervision, I accurately prepared medication for clients through mixing, counting pills and labeling bottles. Completed patient paperwork and insurance claims. Handled inventory and stock medication.