Clinical Research Associate

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

1. Conducts feasibility studies and site qualification visits.
2. Performs all types of visits and site management activities including close-out visits ensuring regulatory, ICH-GCP and Clinical Study Protocol compliance.
3. Develops and ensures strong site relationship through all phases of the trial.
4. Gains an in-depth understanding of the SP/CIP and related procedures.
5. Prepares study documentation e.g. draft CRFs and etc.
6. Conducts Source Document Review of appropriate site source documents and medical records.
7. Collects, reviews, and monitors required regulatory documentation.
8. Communicates with Investigators and site staff on issues related to SP/CIP.
9. Conducts recruitment, retention, SP/CIP deviations, regulatory documentation, site audits/inspections and overall site performance.
10. Identifies, assesses and resolves site performance, quality or compliance problems.
11. Verifies that required clinical data entered in the case report form (CRF) is accurate and complete.
12. Applies query resolution techniques remotely and on-site, and provides guidance to site staff as necessary, driving query resolution to closure within a certain timeline.
13. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture.
14. Verifies site compliance with electronic data capture requirements.
15. Investigational Product review, reconciliation, storage, security and accountability.
16. Investigator Site File review and maintenance.
17. 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.
18. Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings.
19. Participates in project staff meetings (Internal and Sponsor) and attends clinical training sessions according to the project-specific requirements.
20. Assists in planning and execution of Investigator Meetings or other study-related meetings.
21. Other study-specific related tasks and activities.
22. Assume additional responsibilities as required by Project Manager.

Qualifications

• Graduate or postgraduate degree, preferably in the field 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 is 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 being 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 PowerPoint;
• Fluency in English language;
• Clean driving license;
• Willing to travel extensively.

Application link: https://www.jobs.bg/job/6700285