Clinical Research Associate - Nairobi Kenya

Permanent employee Fulltime

• Remote
  
  

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 wellbeing of subjects are protected.

Responsibilities

The roles and responsibilities of the Clinical Research Associate include but are not limited to the following:

• Prepare / collect all documents needed prior to study initiation.
• Monitor patient enrolment to ensure recruitment targets and project timelines are met at the site and/or country level.
• Ensure accurate and timely reporting and follow up of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviations
• Act as the main line of communication between the Sponsor and the site.
• Be a point of contact/liaison for inhouse support services and vendors
• Ensure proper handling accountability and reconciliation of all Investigational Product(s) and clinical study supplies.
• Review the status and contents of essential documents at the site level and reconcile study the Investigator Site File (ISF)/ Electronic Master File (eTMF) at site and/or country level.
• Prepare completion and compilation of regulatory documents such as the ethics committee submission and South African Health Products Regulatory Authority (SAHPRA) requirements when applicable.
• Provide training for colleagues on clinical regulatory administrative and company procedures and processes.
• Improve and develop processes to maintain efficiency in the conduct of clinical trials.
• Participate in feasibility studies.
• Assist with company’s quality control initiative.
• Maintenances of clinical project tracking system of subject and site information.
• Serve as backup for Project Manager when required.
• Present study materials at Investigator/study launch meetings when required.
• Perform necessary administrative functions required by the study (e.g. tracking of expense reports time and attendance).
• Maintain home office (e.g. procurement of office supplies submission of documents).
• Perform necessary functions and as directed any other duties commensurate with the post to ensure the smooth running of operations within the location(s).
• Perform other duties as assigned.
  
  

Experience the ideal candidate will have

• Bachelor’s level degree in life sciences pharmacy nursing or a 3year Diploma in Biological or Health Sciences or appropriate experience in the health care and/or scientific environment.
• 3 years’ experience as a CRA within Clinical Research Organisation / Pharmaceutical company or appropriate clinical trial experience
• Experience with all types of monitoring visits in Phase II and/or III. Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
  
  

Experience You Must Also Have These Skills

• Proven ability to work independently in a fastpaced environment
• Strong communication interpersonal and organizational skills
• Must demonstrate good computer skills
• Position requires approximately 60 travel (up to 80 during peak times).
• Full working proficiency in English.
• Proficiency in MS Office applications.
• Good training and mentoring skills
• Valid driver’s license (if applicable).
  
  

Why us

You will join a young very dynamic and fastgrowing 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 worklife 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 selfreliance 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 www.p95 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 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 NonGovernmental Organizations (NGOs). Our projects focus mainly on infectious diseases particularly on vaccines.

Apply for this job

About Us

P95 an Ampersand portfolio company is a global provider of clinical and epidemiological services related to vaccines and infectious diseases.

Founded in 2011 we are a leader in sourcing analyzing and reporting epidemiological data to assist health agencies and pharmaceutical companies in improving access to safe and effective vaccines.

Headquartered in Belgium P95 has also offices in Europe North America South America South Africa 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 NonGovernmental Organizations (NGOs). Our projects focus mainly on infectious diseases particularly on vaccines.

Apply for this job

We are looking forward to hearing from you!

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