For a full-service CRO located in Sofia, Bulgaria, PAL Recruitment Ltd. is to hire a Clinical Research Associate. Since 2010 the Company has successfully completed more than 32 clinical trials Phase I-IV, including BA/BE studies. Their mission is to improve the quality of human life by making people feel better and trying to help them live longer. They work along with all their collaborators towards the achievement of a common goal: improved health.
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.
- Investigation 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.
Requirements
- Graduate or postgraduate degree, preferably in the field of Biology, Pharmacy, Chemistry or other relevant;
- At least 1 year 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 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.
Like what you read? Sounds like the next adventure? – Do not hesitate to hit the apply.
Application link: https://www.jobs.bg/job/6534708
PAL Recruitment – REG No 3350
