Clinical Research Associate

Description

Summary: The CRA monitors investigational sites to ensure subject safety and quality data, complying with SOPs and guidelines, while building and managing site relationships. Highlights: 1. Ensures subject safety and quality data review and reporting 2. Builds, manages, and supports site relationships as a liaison 3. Opportunity for professional growth in clinical research **Job Description:** -------------------- **Job Location:** China **Job Overview:** The CRA monitors investigational sites to ensure subject safety and provide quality data review and reporting in compliance with the Caidya and/or client Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines, ISO14155 and other applicable regulations. Builds, manages and supports site relationships while serving as liaison between the Sponsor and assigned sites. **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 good 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. * Verifies that the rights and well\-being of trial subjects are protected. * 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. * 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 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. * May provide 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 per project\-specific requirements. **Supervisory Responsibilities:** None **Job Requirements:** * Education + 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 communication and 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 + Good documentation skills; good command of English and the local language in the area of activity (reading, writing, understanding) * 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. \#LI\-XX1 The company will not accept unsolicited resumes from third party vendors.