Summary
Overview
Work History
Education
Skills
Certification
Interests
Timeline
Generic

Siphokazi Dayimane

Clinical Research Associate 1
Cape Town, South Africa

Summary

Detail-oriented Clinical Research Associate with hands-on experience as a Clinical Trial Assistant at IQVIA in clinical trial execution and regulatory compliance. Skilled in clinical documentation management and effective communication, I excel in fostering collaboration among cross-functional teams. My proactive approach has consistently ensured data integrity and patient safety throughout all study phases, contributing to successful trial outcomes.

Overview

9
9
years of professional experience
2
2
Certifications
3
3
Languages

Work History

Clinical Research Associate 1

IQVIA
09.2024 - Current
  • Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
  • Provide monitoring visits and site management for a variety of protocols, site and therapeutic areas.
  • Administer protocol and related study training to assigned sites and establish regular line of communication with sites to manage ongoing project expectations and issues.
  • Evaluate the quality and integrity of study site practices related to proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals. recruitment and enrollment, case report form completion and submission and data query generation and resolution.
  • Supported the successful completion of clinical trials by proactively managing risks and addressing challenges throughout all stages of the study process.
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
  • Build awareness of features and opportunities of study to site.
  • Collaborate and liaise with study team members for project execution support as appropriate.

Clinical Trial Assistant

IQVIA
10.2020 - 03.2024
  • Providing administrative support to projects and assist with general administrative functions
  • Assist Clinic Research Associates(CRAs) and Regulatory and Start-Up(RSU) team with accurately updating and maintaining clinical documents and systems that track site compliance and performance within project timelines.
  • Assist the clinical team with the preparation, handling, distribution, filing and archiving of clinical documentation and reports according to the scope of the work and standard operating procedures.
  • Assist with periodic review of study files for completeness.
  • Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
  • Assist with the tracking and management of Case Report Forms(CRFs), queries and clinical data flow.
  • Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
  • Accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.

Chemistry Tutor

University Of Cape Town Tugwell Residence
02.2016 - 11.2016
  • Provide academic support to 1st year students.
  • Participated in monthly meetings and workshops.
  • Fostered a positive atmosphere conducive to productive learning by consistently displaying enthusiasm about the subject matter at hand.


Education

Bachelor of Science - Biochemistry

University of Cape Town
Cape Town
04.2001 -

Bachelor of Science - Chemistry

University of Cape Town
Cape Town
04.2001 -

Skills

Clinical documentation management (TMF)

Clinical data management

IRB submissions

ICH guidelines

Communication & Coordination

Attention to Detail

Administrative and Tracking tools ( CTMS, eTMF)

Clinical monitoring

Protocol & Good clinical practice knowledge

Source Data Verification

Data Query Management (Medidata Rave)

Analytical Thinking

Detail-oriented mindset

Time management and multitasking

Collaboration in fast-paced environments

Time management and multitasking

Certification

Fundamental GCP accreditation

Interests

Traveling

Reading

Exploring different cuisines

Gym

Timeline

Clinical Research Associate 1

IQVIA
09.2024 - Current

Good Clinical Practice Fundamentals

10-2022

Clinical Trial Assistant

IQVIA
10.2020 - 03.2024

Fundamental GCP accreditation

10-2020

Chemistry Tutor

University Of Cape Town Tugwell Residence
02.2016 - 11.2016

Bachelor of Science - Biochemistry

University of Cape Town
04.2001 -

Bachelor of Science - Chemistry

University of Cape Town
04.2001 -

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Siphokazi DayimaneClinical Research Associate 1