Melissa Cherepa

Serve as a Field CRA Liaison to aid in communication and collaboration between field, site and trial management Contribute to various working groups to improve efficiencies within systems and processes Provide trial management at the site level Ensure compliance with protocols, ICH-GCP, Canadian regulatory requirements, local ethics requirements and sponsor Standard Operating Procedures (SOPs) Main contact for trial site personnel, provide ongoing training and support related to protocol/logistics to ensure site milestones are achieved Assist in investigator study site selection and study start-up Conduct close out visits Identify site issues and initiate correction plans based on monitoring reports Perform investigative site file reconciliation: request any new and updated site-related essential/non-essential documents and review them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project SOPs, and sponsor requirements Verify drug accountability logs and storage requirements Provide study status updates to team members and project management, including interaction to resolve site issues and facilitate project timelines

Coordinate multiple concurrent clinical trials in various disciplines from pre-screening to completion including recruitment Manage and train the clinical research team (including full time research assistant, part-time research assistants, pharmacists, ECG technicians, part-time infusion nurse) Responsible for accurate and timely data collection, documentation, data entry, and reporting adverse events and protocol deviations to regulatory authorities Maintain and negotiate budgets for each clinical trial and provide forecasts for revenue Develop and revise all site specific SOPs and source documents Perform pulmonary function tests, ECG, and health assessments according to protocols Perform venipuncture, and process and ship laboratory samples Performed very well in Health Canada audit

Triage phone calls and perform health assessments over the phone Perform history taking, physical and psychosocial assessments and health education and document findings in electronic medical records Administer injections and assess for adverse reactions Maintain INR monitoring and management system

Perform physical and psychosocial patient assessments and provide health teaching Develop, implement and provide health education programs Conduct disease screening (e.g. diabetes, breast cancer) and refer to appropriate resources if needed Ability to prioritize and organize work activity and provide work direction to staff members in order to complete assignments Coordinate multiple clinical trials in various disciplines (e.g. diabetes, chronic pain, Alzheimer's, menopause) from pre-screening to completion Perform various study-related tasks (e.g. ECG, spirometry, TnSN, mini-mental exams, data collection, sample collection, drug accountability)

Triaged phone calls in a fast paced computerized medical office Assisted with procedures (i.e. pap smears, patient vitals, suture removal) Prepared and administered injections Discussed test results and answered questions regarding health promotion and disease prevention Maintained INR monitoring and management system

Facilitated emergency patient referral and communication services for healthcare providers in Ontario Maintained multiple comprehensive data systems Excellent problem-solving abilities, conflict resolution and extensive knowledge of provincial hospitals and their resources Applied analysis and critical thinking to the selection of an appropriate medical specialist based on information provided by the caller Recognized the needs of callers, the acuity of situations and respond quickly and effectively while maintaining patient confidentiality

Triaged phone calls in a fast paced computerized medical office Used time management skills to coordinate multiple clinical drug studies Responsible for data entry, verification and management Conducted medical procedures, i.e. electrocardiographs Planned, coordinated and scheduled meetings with Research Associates Prepared documents and lab kits for clinical study visits Responsible for drug accountability and dispensing of study medication