The Clinical Research Associate II (CRA II) will perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned physician/investigative sites to ensure clinical trials are conducted, recorded and reported in accordance with the study protocol/clinical investigation plan, CRO and Sponsor standard operating procedures, ICH-GCP and/or all applicable local regulatory requirements.
Responsibilities
- Conducts feasibility studies and site qualification visits
- Performs all types of visits and site management activities including close-out visits ensuring regulatory, ICH-GCP and Clinical Study Protocol compliance
- Develops and ensures strong site relationship through all phases of the trial
- Gains in-depth understanding of the SP/CIP and related procedures
- Prepares study documentation e.g. draft CRFs and etc.
- Conducts Source Document Review of appropriate site source documents and medical records
- Collects, reviews, and monitors required regulatory documentation
- Communicates with Investigators and site staff on issues related to SP/CIP
- Conducts recruitment, retention, SP/CIP deviations, regulatory documentation, site audits/inspections and overall site performance
- Identifies, assesses and resolves site performance, quality or compliance problems
- Verifies required clinical data entered in the case report form (CRF) is accurate and complete
- Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within certain timelines
- Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
- Verifies site compliance with electronic data capture requirements
- Investigational Product review, reconciliation, storage, security and accountability
- Investigator Site File review and maintenance
- Compiling confirmation letters, follow-up letters, trip reports, communication logs, site staff training logs and other required project documents as per SOPs and Projects Clinical Monitoring Plans/Site Management Plans.
- Prepares for and attends Investigator Meetings and/or sponsor face to face meetings
- Participates in project staff meetings (Internal and Sponsor) and attends clinical training sessions according to the project specific requirements
- Assists in planning and execution of Investigator Meetings or other study related meetings
- Other study-specific related tasks and activities
- Assume additional responsibilities as required by Project Manager
Qualifications
- Graduate or postgraduate degree, preferably in the filed of Biology, Pharmacy, Chemistry or other relevant
- At least 3 years of experience as a Clinical Research Associate/Clinical Monitor with a CRO or Pharma company required
- Excellent knowledge of clinical research process
- Good knowledge of all functional areas of clinical trial management
- Working knowledge of current ICH/GCP guidelines and applicable country-specific regulations
- Well-organized, ability to prioritize, quickly adapt to an environment of changing priorities to achieve goals
- Demonstrating good computer skills and able to embrace new systems and technologies
- Good analytical and problem-solving skills
- Ability to travel for site monitoring and/or co-monitoring activities, attend investigator meetings or vendor visits/audits, as required (up to 30%)
- Ability to keep tight deadlines and work in a dynamic environment
- Working knowledge of Word, Excel, and Power Point
- Fluency in English language
- Clean driving license
- Willing to travel extensively
Application link: https://www.jobs.bg/job/7612257
