City of Cape Town
Cape Town, Western Cape
NUES LLC is seeking a Clinical Research Associate (CRA) in Infectious Disease, contingent upon contract award, in South Africa.
- Perform all required activities to ensure appropriate monitoring and management of investigator sites are conducted as per ICH GCP, Ethics and Regulatory requirement and the sites SOPs.
- Perform all types of monitoring visits: Pre-Study, Study Initiation, Routine/Interim and Close-out visits.
- Ensured preparation, collection and distribution of trial master file documents and maintenance of investigator site file
- Perform monitoring visits according to monitoring plan (including trial initiation,
training and closeout activities)
- Complete interim monitoring visits in accordance with relevant SOPs, regulatory requirements and guidelines, the study protocol, project plan and clinical study monitoring plan
- Perform other duties as assigned
- MS degree or BS/BA degree with three (3) additional years of experience may be substituted.
- Minimum Experience Five (5) years of related experience
- TB trial experience
- Must demonstrate experience with FDA regulatory requirements.
- Must demonstrate experience and working knowledge of ICH, GCP and regulatory agency requirements both domestically and internationally
- Must have experience in working with multi-disciplinary teams across various aspects of clinical trial development.
- Must have a high proficiency of written and spoken English.
- Must have proficiency with an office productively suite such as Microsoft Office, Adode, MS Word, Excel, and Outlook especially electronic spreadsheet functions and word processing software
- Demonstrates critical thinking skills and attention to detail
- Excellent communication skills, both written and verbal, and the ability to give and receive honest and direct feedback
- Excellent teamwork and interpersonal skills, with calm demeanor and positive attitude under pressure
Equal Opportunity Employer
NUES LLC is an equal opportunity employer. Our policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category.
Applicants must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire.
The Company will not sponsor applicants for work visas.
Job Types: Part-time, Contract
- HIV: 3 years (Preferred)
- TB: 4 years (Preferred)
- Trial Monitoring: 5 years (Preferred)
- Bachelors (Required)