Clinical Research Associate Ii
il y a 2 semaines
**Job Title**:Clinical Research Associate II**Job Location**:Paris - France (Home based - any location in France considered)Caidya has an exciting opportunity for a CRA with experience in monitoring early phase oncology projects to join our growing team in France
**Job Overview**:
**Job Duties and Responsibilities**:
- 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 or investigational plan 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.
- May support translations of essential documents
- May support submission of trials to IRB/IEC and regulatory authorities.
- Performs source data verification against Case Report Form/Electronic Data Capture entries in compliance with the Monitoring Plan. Ensures accurate and complete data and that corrections are appropriately documented by authorized site staff.
- Verifies the quality of all recorded data. Issues and ensures timely resolution of all data queries remotely or at investigator site.
- Performs Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.
- Verifies and supports the recording and reporting of adverse events/serious adverse events. 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 investigative sites in respect to the trial conduct 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.
- Participates in relevant trial meetings, e.g. Kick off, Investigator, and Monitor meetings.
- Participates in site audits, as requested.
- May conduct site and study feasibility assessments.
- May be involved in the development of monitoring guideline and tools.
- Provides input into study documentation and monitoring worksheets.
- Uphold the confidentiality agreements with all clients and colleagues outside Caidya.
- Pays attention to signals of fraud, misconduct and escalates per Caidya SOP.
- Work according to the Caidya 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 Caidya 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 Clinical Operations Manager/Project Manager and per project-specific requirements.
- May participate in delivering Clinical Monitoring portion of a bid defense presentation.
**Supervisory Responsibilities**: None
**Job Requirements**:
- Education
- 4 year college graduate, preferably with a healthcare or life science degree.
- Experience
- Minimum of 1 year of experience in on
- site monitoring clinical studies.
- Experience in oncology studies
- Experience in early phase development
- Skills/Competencies
- Strong written and verbal communication skills
- Strong interpersonal skills
- Strong monitoring skills to independently conduct all types of site monitoring visits
- Good documentation skills; good command of English and the local language in the area of activity (reading, writing, understanding)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
- Strong 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 ca
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