- Responsible for the oversight of clinical research conducted at investigational sites and monitors progress of clinical trials to ensure compliance with study protocols, applicable regulatory standards, Ethics committee/Institutional Review Board (IRB/EC) policies as well as procedures and business policies.
- This position works under supervision as needed, working closely with study management teams
- Performing monitoring activities of clinical trials at the site or remotely and ensuring all is conducted, recorded and reported in accordance with the Investigational Plan, Monitoring Plan, standard operating procedures (SOP), good clinical practices (GCP), and other applicable regulatory requirements.
- Communicate visit findings with site personnel and complete a written letter for distribution to the Principal Investigator and appropriate site personnel for follow-up.
- Prepare site visit reports and correspondence for all visits conducted in accordance with the study Monitoring Plan.
- Identifies and escalates protocol deviations, discrepancies in data, and non-compliance to study protocols, applicable regulations, Good Clinical Practices and Standard Operating Procedures
- Collaborates with monitoring management and study team personnel towards securing Investigator compliance
- Identifies site needs and provides solutions to facilitate the clinical trial process.
- Act as primary point of contact for study sites as requested.
- Responsible for reviewing adverse event cases with investigators, preparing study documents, and issuing status reports.
- Understands the study protocol and accompanying background information
- Performs initial and ongoing site personnel training as required.
- Has soft skills experience in site management
- Be a team player
- Able to accept review of reports being rated by our review team
- Able to submit reports on time
- Clear and effective communication verbally and in writing.
- Bachelor or Master?s degree in life sciences, nursing or other health related disciplines
- Demonstrated experience in Clinical Research Monitoring.
Competencies and essential skills in the following:
- Cross-functional relationships, decision-making, execution/results/process improvement, customer satisfaction
- Ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands
- High attention to detail and accuracy
- Good problem-solving skills
- Work with Word, PowerPoint, Excel spreadsheets and databases applications
- Good understanding of any applicable regulations and standards (e.g., Training on Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical research ethics, EU Directive, etc.)
- Business knowledge or experience with the medical/healthcare industry, knowledge of medical terminology.
- Fluent in Hungarian and English.
- Ability to travel (25-75%).
Please contact me on 01727 817600 or email@example.com
- Agency: Achieva Group Limited
- Contact: Fandi Hatib
- Phone: +44 (0)1727 811 634
- Reference: 32279
Website: Achieva Group Limited
- Updated: 30th September 2021
- Expires: 28th October 2021