Dados da Vaga de Emprego
Clinical Research Associate I – 132308920
- 4 year college graduate, preferably with a healthcare or life science degree. In lieu of a degree, candidates with 1 or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.
- Experience: Less than 1 year of experience in on-site monitoring clinical studies.
- Skills/Competencies: Good interpersonal skills, Good monitoring skills to independently conduct all types of site monitoring visits, Proficient computer skills, including Microsoft Office, Comprehensive knowledge of GCP/ICH guidelines, Proficiency in medical terminology Able to exercise judgment within defined procedures and practices and to determine appropriate action independently. Attention to detail Problem-solving skills Ability to work in a matrix environment Good time management and organizational skills.
- Capabilities: Ability to drive an automobile and have a valid driver’s license, if applicable, Valid passport required in the case of international business travel. Ability to travel up to 80%.
Atribuições e Responsabilidades
- Provides support to Project Team and Clinical Operations Team. Maintains working knowledge of protocols and Monitoring Plans for assigned projects. Demonstrates strong written and verbal communication skills. Serves as primary contact for assigned research sites. Verifies that the investigator, staff, and site facilities remain adequate throughout the trial period. Responsible for scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan. Ensures assigned sites are conducting studies according to protocol requirements and applicable regulations and guidelines. Reconciles site regulatory binder assuring collection and completeness of regulatory documents. Collects and ensures completeness of all essential regulatory documentation from sites from study start-up through close-out. Verifies that written informed consent was obtained before each subject’s participation in the trial. Verifies that the investigator is enrolling only eligible subjects. Performs verification of source document s against Case Report Form/Electronic Data Capture entries to assure accurate and complete data. Ensures that any corrections are appropriately documented by authorized site staff. Issues and ensures timely resolution of all data queries. Performs Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records. Ensures all types of adverse events are reported and tracked per regulatory requirements and the Monitoring Plan. Ensures that sites have sufficient project specific supplies.
- Manages and motivates sites to meet study goals. Communicates deviations from the protocol, SOPs, and/or GCP, to the investigator, and project management team and takes appropriate action to prevent recurrence. Delivers quality written trip reports, confirmation and follow-up letters within timelines of SOPs and Monitoring Plans. Attends and participates in team teleconferences and training. Attends investigator meetings. Participates in site audits, as requested. May makes recommendations for improvement in processes. May conduct site and study feasibility assessments. May be involved in the development of monitoring guideline and tools. May provide input into study documentation and monitoring worksheets. Uphold the confidentiality agreements with all clients and colleagues outside Clinipace Worldwide (CPWW). Work according to the CPWW Quality Management System and actively participate in giving feedback and suggesting improvements to current processes. Work according to the project-specific timelines and budget agreement, which has been agreed upon with the sponsor. Accurately document the time spent per project in the CPWW time allocation system. Demonstrates flexibility and adaptability. Proactively identifies, manages, escalates (as needed) and resolves site issues effectively and independently. Other duties as assigned by Lead Clinical Research Associate/Clinical Trial Manager/Project Manager per project-specific requirements.
ResumoTipo de Contrato: Efetivo (CLT)
Salário: não especificado
Local: São Paulo - SP