About P95 P95, an Ampersand portfolio company, is a
global provider of clinical research and epidemiology solutions
focusing on vaccines and infectious diseases.
Founded in
2011, we are a leader in sourcing, analysing, and reporting
epidemiological data to assist health agencies and pharmaceutical
companies in improving access to safe and effective vaccines. We have
offices in Europe, Latin America, and SE Asia.
We are
passionate about healthcare and helping our customers with innovative
medical research. We share a sense of urgency with our customers to
deliver timely, pragmatic and useful insights to improve
healthcare.
Our clients are from the pharmaceutical
industry, public health institutes, academic institutions, WHO, the
European Commission and other governmental organizations and
Non-Governmental Organizations (NGOs). Our projects focus mainly on
infectious diseases, particularly on vaccines.
Job purpose
The Clinical Research
Associate (CRA) acts as a primary contact for key players in clinical
trials, including investigators, site staff, sponsors, ethics
committees and regulatory authorities. The CRA monitors and manages
quality control of research projects, ensuring compliance with
established protocols, Good Clinical Practice/Good
Pharmacoepidemiology Practice, regulatory guidelines and regulations,
and standard operating procedures. The CRA ensures accuracy and
validity of data, and that the rights, safety, well-being of subjects
are protected.
Responsibilities
The roles and responsibilities of the Clinical Research Associate
include, but are not limited to, the
following:
- Prepare and conduct study feasibility,
site selection, study start-up, initiation, monitoring and close-out
visits in accordance with standard protocol, regulatory requirements
and good clinical practices
- Perform on-site and remote
monitoring visits and site management in accordance with the
monitoring plan
- Support the implementation of site
recruitment plan and retention strategies
- Ensure the quality
and integrity of site practices and that the study is conducted in
compliance with the protocol, GCP, applicable laws and regulations and
SOPs
- Write and submit monitoring visit reports of site
findings
- Escalate compliance issues and implement corrective
and preventive actions as appropriate
- Participate in
investigators meetings as necessary
- Maintain required
essential documents throughout the complete study cycle
- Establish regular lines of communication with the assigned
sites, the sponsor company and internal project teams
- Ensure
site adherence to study timelines, quality of site data and data query
resolution
- Ensure all clinical trial management systems are
complete, accurate and updated
- Participate in audit
preparation and follow-up activities as necessary
Why us?
You will join a young,
very dynamic, and fast-growing private research organization. Our
passionate, truly multicultural, and diverse team of more than 115
colleagues and nearly 40 nationalities include epidemiologists, data
scientists, statisticians, data analysts, medical writers, safety and
pharmacovigilance specialists, project managers and business support
professionals spreading over 20 countries.
We all work
remotely, setting our own time schedule, based on a “getting the job
done” mentality. This has a positive impact in our work-life balance.
Our headquarters are in Leuven (Belgium), but we also have local and
regional offices located in Rotterdam (the Netherlands), Bogota
(Colombia) and Bangkok (Thailand). You may need to travel
occasionally to our Leuven office.
At P95, we are a
collaborative and international team that works on diverse projects,
topics, and clients and faces interesting challenges. There is a high
level of empowerment, flexibility, autonomy as well as opportunities
for research and development, to make things happen. We have an open
culture of respect and inclusion. Consequently, we value
self-reliance, initiative, and responsibility of everyone in our team
to meet our internal and external customers’ expectations. Finally,
our colleagues experience a strong sense of meaning and purpose driven
by the scientific nature and impact of our work.
Do you want to
join us? Visit our website
to learn more about who we are and what we do. If you are
the one for this job, send your application by filling out the
following short form. The call will remain open until the position is
filled.
P95 is an Equal Opportunities Employer. The
company is committed to equal employment opportunities regardless of
age, sexual orientation, gender, pregnancy, religion or belief, union
belief, wealth, birth, nationality, ethnic origin, disability, medical
history, skin color, marital status, genetic information, parental
status, social origin, or condition. We base all our employment
decisions on merit, job requirements and business needs.
About us
P95, an Ampersand portfolio company, is a
global provider of clinical research and epidemiology solutions
focusing on vaccines and infectious diseases.
Founded in 2011, we are a leader in sourcing, analysing, and
reporting epidemiological data to assist health agencies and
pharmaceutical companies in improving access to safe and effective
vaccines. We have offices in Europe, Latin America, and SE Asia.
We are passionate about healthcare and helping our
customers with innovative medical research. We share a sense of
urgency with our customers to deliver timely, pragmatic and useful
insights to improve healthcare.
Our clients are from the
pharmaceutical industry, public health institutes, academic
institutions, WHO, the European Commission and other governmental
organizations and Non-Governmental Organizations (NGOs). Our projects
focus mainly on infectious diseases, particularly on vaccines.