Clinical Research Associate / QA
Arianne Corp
Total des années d'expérience :11 years, 8 Mois
Implement and monitor clinical trials in all phases of drug development.
Conduct pre-study, initiation, routine, and closeout
visits and report findings in a site visit report.
Conduct quality assurance activities to assure the compliance of company
SOPs, FDA and ICH guidelines of contract research organizations, study
coordinators, investigators, and independent consultants.
Assist in regulatory filings with local agencies.
Adhere to company SOPs, FDA regulations, ICH guidelines and Algerian
Guidelines.
Track clinical data, regulatory documents, patient enrollment, and
data resolutions to assure the timely completion of clinical studies.
Communicate with sites, clinical vendors, and others within the
company, both in and outside the department.
Act as primary contact to sites.
Review and resolve discrepancies in clinical data at clinical sites
and central laboratories via query process.
Provide technical and administrative assistance to the department.
Identify and assist in the selection and implementation of clinical sites.
Select, design and implement the data collection method and tools
with vendors.
Assist in the creation of informed consents, case report forms,
instruction manuals, Newsletter, and monitoring and tracking tools.
Oversee delivery and shipment of clinical trial supplies and
ensure accounting of usage in clinical studies.
Perform clinical finance duties (site payments, CRO payments etc.)
Organize and maintain study documents (TMFs, regulatory binders etc.)
QA activities related to clinical studies and company QA activities
Perform other duties as required.
Involve in the collection and processing of cytological and histopathological
samples for diagnosis.
Operate Abbott Ruby Cell Dyn and Emerald Hematology analyzer
Operate Abbott integrated Chemistry and Immunology analyzer ( Ci4100).
Keep accurate records and writing reports.
Write research grants and protocols.
Maintain and update professional knowledge and taking responsibility
for continuing professional development
Analyze the CD4 level, hematological parameters, liver function enzymes and Kidney function parameters in HIV blood samples.
Create and manage laboratory documentation in accordance to Good Clinical Laboratory Procedure.
Write and document laboratory results for research and standardization purpose.
Perform both internal and external quality control.
Supervise day-to-day activities both in the laboratory and the administrative section.
Evaluate, hire job applicants, and organize training and laboratory orientation.
Arrange work schedules, review staff performance and handle disciplinary actions, bonuses and firing.
Establish laboratory procedures, create and manage laboratory documentation and organize laboratory activities.
Serve as primary point of contact with clients to provide information and take request for services.
Supervise the maintenance of the laboratory and the equipment
Establish quality standards and supervise quality control.
Assess the progress made in implementing the community engagement plan at NHVMAS trial site, national and international levels in pursuant of its aim of engaging all relevant stakeholders in the NICCAV project.
Assess the systems and processes put in place for the implementation of plan e.g data collection, collation, analysis, dissemination and use.
Identify challenges and bottlenecks that hamper the implementation of the community engagement plan.
Develop and administer the evaluation survey instruments.
Analyze and synthesize findings from the review and agree on modalities for improvement.
Set programme priorities for the following year.
Submit a soft copy of the evaluation report.
Involve in laboratory-based task such as sampling, testing and measuring in the field of medicine by examining tissue samples. Preparing slides of body cells and examining them microscopically for abnormalities that may signal the beginning of a cancerous growth. Studying the structures and functions of the different types of blood cells.Involved in Quality Management and Control Assurance. Collecting, typing and preparing blood and its components for transfusions. Preparing specimens and analyzing the chemical and hormonal contents of body fluids. Examining and identifying bacteria and other microorganisms causing disease. Examining elements of the human immune system and its response to foreign bodies. Identifying infections and viruses such as hepatitis and HIV. Proficiency in Microsoft windows and Statistical Package for the Social Sciences (SPSS).