Clinical Research Associate NDOVU Study Project.pdf
- Nairobi
- Permanent
- Full-time
protocol, International Council for Harmonisation Good Clinical Practice (ICH GCP)
guidelines, ethical review committees and regulatory guidelines, and all other applicable
laws so that human subjects are protected and data produced is of integrity. He/she will
lead study monitoring and quality assurance and advise the Principal Investigator on
study design and conduct and oversee GCP and human subjects' protection (HSP)
training, certification and adherence for all study personnel.
Job Title: Clinical Research Associate (CRA)
Duty Station: University of Nairobi
Reporting to: Chief Investigator
Job Description
1. Champion participant safety and wellbeing, rights and confidentiality
2. Ensure appropriate GCP and HSP training, certification and practice for all study
personnel
3. Participate in study design and planning including pre-study assessment for study
sites, development of study materials, compilation of the investigator site file, and
pre-study trainings
4. Work with the study team to oversee ERC and regulatory submissions,
responses, renewals, amendments, notifications and communications
5. Ensure appropriate training of study personnel on the study, including protocol,
refresher and remedial trainings
6. Oversee the informed consenting process
7. Assist the Study Coordinator in the maintenance of investigator site files
8. Develop monitoring plan for all supported studies
9. Conduct site monitoring visits as per the monitoring plan including oversight of
independent monitors.
10. Regularly review study data including conducting source data verification, raise
data queries, and review resolution of queries to ensure integrity of study data.
Page 1 of 211. Prepare sites and participate in sponsor, ERC and regulatory audits
12. Work with study sites to address monitoring and audit findings
13. Oversee study close-out including ensuring appropriate disposal of investigational
products, archiving of study documents, and closure of study sites as needed
14. Any other duties assigned by the supervisorJob Specifications
i. Bachelor degree in a health-related field
ii. Registered healthcare practitioner with a valid practice certificate
iii. MUST have a current Certificate of Good Clinical Practice
iv. MUST have a current certificate in Human Subject Protection
v. Certificate in clinical trial monitoring
vi. Previous experience working as the main Study Monitor for at least two large
clinical trials
vii. Previous experience supporting regulatory compliance for multiple clinical trials
viii. Experience with a multi-country clinical trial is an added advantage
ix. Good communication skills
x. Willing to travel extensively and on short noticeTerms of appointment
The appointment is on contractual terms of one year, renewable based on performance
and mutual agreement.
Notes1. Applicants should email their application letters, certified copies of certificates and
curriculum vitae (CV) giving details of their qqualificationons, experience and three
(3) referees indicating their telephone contacts and e-mail contacts;
2. Applications and related documents should be forwarded addressed to the Director,
Human Resource, University of Nairobi;
3. Applicants should state their current designations, salaries and other benefits
attached to those designations;
4. The application letter must bear the reference code indicated in the advertisement;