We are seeking to hire an experienced Clinical Research Associate in (Uganda, Tanzania, Kenya, Ghana, Mali, Malawi, and Zimbabwe) to help us keep growing. If you're dedicated and ambitious, Xcene Research is an excellent place to grow your career.
Oversees the development of clinical trial protocols; participates in the development of the overall clinical plan, drafts protocols, collaborates on statistical analysis plans, and coordinates the protocol review and approval process, to include submissions to regulatory agencies.
Participates in the identification of potential investigators and clinical sites, both nationally and internationally; conducts pre-study site visits, collects and reviews data, and prepares evaluative reports; participates in the final selection of investigators and study sites.
Assists in the identification of contract research organizations and centralized services such as clinical laboratories; assesses qualifications and experience in relation to proposed research activities and participates in final selection.
Assists with the development and implementation of study-specific monitoring and reporting procedures, methods, guidelines, and tools; participates in the establishment of baseline parameters and edit check specifications, and in the development of subject tracking systems.
Conducts clinical trial site initiation visits; advises and trains site personnel on sponsor and regulatory requirements for study conduct; participates and/or conducts site meetings and multicenter investigator meetings and prepares reports.
Conducts site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with state and federal regulations, guidelines, and policies.
Reviews on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides remedial training and/or initiates corrective action as required.
Ensures appropriate transmission of clinical case data to the data management centers; reviews case report queries and problems and clarifies and/or obtains changes to data as appropriate.
2+ years of prior clinical research experience
Nursing, Pharmacy, Medicine or Life Science degree
Must possess superior analytical and creative thinking skills
Excellent attention to detail and the ability to keep detailed, accurate records
Strong written and verbal communication skills
Understanding of laboratory procedures and equipment
Advanced organizational and planning skills
Proficiency in MS Word and Excel programs
Ability to stand for extended periods of time
Must be fluent in English and posses solid writing abilities