Vjolicoeur DIVAWIFEY

Managed multiple (Phase I-V) studies while adhering to SOPs, GCPs, and study protocols. Ensured all documentation was complete and timely according to FDA and sponsor guidelines, and properly documented and reported adverse events.

Implemented and monitored clinical studies at participating sites according to FDA's Code of Regulations (CFR), Good Clinical Practice (GCP), and ICH Guidelines. Responsible for overall study planning, ensuring all visits, monitoring, data collection, and reports met company deadlines and quality expectations.

Managed assigned studies from beginning to end, assisting in internal quality improvement and identifying project guidelines. Collaborated with key stakeholders to develop study startup activities and associated documents.

Provided research services and administrative support, facilitating biomedical human research protocols. Enrolled eligible subjects into clinical studies through informed consenting in accordance with GCP.

Supported research and development for clinical trials in accordance with regulatory and Abbott requirements. Monitored and ensured the safety of subjects participating in clinical trials.

Coordinated travel and pediatric immunizations, pulmonary function testing, and research in major sports medicine and orthotics. Performed EKGs and assisted physicians with vital signs, casts, and general orthopedic care.

Supervised nine medical assistants across seven divisions, including Respiratory, Cardiology, and Nephrology. Conducted and recorded patient vital signs, temperature, and growth analysis.

Maintained daily records and ran complete blood count (CBC) profiles, urinalysis, and drug testing. Served as manager for the processing center as needed.

Obtained vital signs, ordered laboratory work (hemoglobin A1C tests, blood sugars), and submitted prescription information. Assisted nurses with triage.

Performed vital signs and obtained patient history. Prepared patients for and assisted physicians during examinations.

Performed venipuncture, patient triage, and direct patient care/education for various clinics including colposcopy, gynecological, and pediatric. Collected vital signs and recorded findings and biopsy results.

Completed an Associates in Medical Technology program. Obtained certifications in Medical Assistant/Technologist and Drug Testing. Gained knowledge in various medical technologies and diagnostic procedures.