As Clinical Research Associate, Late Phase at Mapi Group, you will be responsible for performing all monitoring and site management activities within the monitoring and site management (MSM) team. You will perform routine site visits to ensure that the rights and well-being of human subjects are protected; the trial data is accurate, complete, and verifiable from source documents. You will ensure that all activity is delivered in accordance with the study protocol, GCP/ICH/GEP guidelines and applicable regulatory requirements.
- Perform site feasibility and site selection in conjunction with Site Management Associates, or independently.
- Work closely with relevant departments to perform Regulatory and IEC/IRB submissions and contract negotiations
- Perform site and remote visits including pre-study, site initiation, interim and close out to monitor informed consent procedures, compliance protocol, GCP/ICH guidelines and other applicable regulatory requirements
- Contribute to and where necessary lead; sponsor or regulatory site audits/inspections including preparation , attendance and follow-up audit findings
- Maintain regular site contacts to ensure site compliance, enrolment and understanding of study requirements
- Maintain the Project Tracking System recording site visit dates, site contact notes, subject and site information
- Write and review project plans and templates
- Assist with the development of departmental and project specific processes and procedures
Knowledge, Skills and Attributes
- Strong knowledge of ICH/GCP guidelines and/or other relevant guidelines (GEP, GPP) and local requirements (including regulatory)
- Proficiency with computer/software systems
- Proven ability to project manage multiple simultaneous tasks
- For non-native English speakers; possess strong written and verbal English skills
- Three (3) year degree preferably in a scientific, medical or life sciences discipline or considerable relevant practical and professional experience
- Clinical Research Certification is highly desired
What will you get?
Values: At Mapi, we embrace our values, and everyone that works here is expected to demonstrate these values and associated behaviours in their day-to-day work. Our values are the foundation of the work we do, and include ownership, transparency, fairness, adhere to beliefs, adaptation, empathy and sincerity….to name but a few.
Culture: We promote personalisation as part of our culture, where each individual has a voice and can be heard. Our teams are diverse, multicultural and experts in their own field. To fit in culturally at Mapi, you will need to believe in and evoke our values.
At Mapi, we are committed to improving the quality of patient care worldwide. We do this by offering strategic and insightful solutions for successful market access to people who are shaping tomorrow’s health care. Our values serve as the guiding principles in fulfilling our commitments to the patient and to our clients.