MSD Pretoria South Africa
2 weeks ago
MSD's job vacancy, Career and Recruitment
Job title :
Sr. Clinical Research Associate jobs in Gauteng
Job Location :
June 04, 2023
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The role is accountable for performance and compliance for assigned protocols and sites in a country.
Under the oversight of the CRA manager or Clinical Research Director, the person ensures compliance of study conduct with ICH/Good Clinical Practice and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as Subject Matter Expert for monitoring processes and... systems.
Qualifications, Skills & Experience
Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
Demonstrated ability to mentor/lead.
Hands on knowledge of Good Documentation Practices.
Proven Skills in Site Management including independent management of site performance and patient recruitment.
Demonstrated high level of monitoring skill with independent professional judgment.
Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
Ability to understand and analyze data/metrics and act appropriately, also in a virtual environment.
Experience with conducting site motivational visit designed to boost site enrollment.
Capable of managing complex issues, works in a solution-oriented manner.
Performs root cause analysis and implements preventative and corrective action.
Capable of mentoring junior Clinical Research Associates on process/study requirements and is able to perform co-monitoring visits where appropriate.
Min. 4 years of direct site management (monitoring) experience in a bio/pharma/CRO.
B.A./B.Sc. with strong emphasis in science and/or biology.
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