Responsibilities may include the following and other duties may be assigned.
? 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, personnel and site personnel for resolution of site issues towards successful clinical studies execution.
? 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 to follow-up.
? Prepare site visit reports and correspondence for all visits conducted in accordance with the study Monitoring Plan and within timelines for visit deliverables.
? 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 main 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 (e.g., Investigator Brochure, Report of Prior Investigations etc.).
? Performs initial and ongoing site personnel training as required.
? Attend internal department and (study) team meeting as requested
? Adhere to all applicable company policies and procedures
? Responsible for planning, preparation, and execution of the study submission to Ethics Committees (EC/CA) for initial and subsequent submissions.
? Supports Clinical Trial Agreement (CTA) process, invoice and payment requests.
? SPECIALIST CAREER STREAM:
- Bachelor or Master?s degree in life sciences, nursing or other health related disciplines
- Demonstrated experience in Clinical Research Monitoring.
? DIFFERENTIATING FACTORS Autonomy:
- Clear and effective communication verbally and in writing.
- Good interpersonal skills and comfortable with working with others
- Proactivity, ability to work in a fast paced and changing environment
- Ability to work in a matrix environment.
- 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 preferably located in Hungary
- Demonstrated experience in planning/ preparing/ execution of study submission to EC/CA.
- Ability to travel (25-75%).
Nice to have:
- Additional language skills and/or monitoring experience in CEE region.
- Agency: Achieva Group Limited
- Reference: LC-12
Website: Achieva Group Limited
- Posted: 17th June 2022
- Expires: 15th July 2022