ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, they advance clinical research by providing outsourced services to pharmaceutical, biotechnology, medical device, and government and public health organization.
Full Job Description
Clinical Study Coordinator Johannesburg South Africa
With their patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
The people are our greatest strength, are at the core of the culture, and are the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what they do.
Trial and site administration:
- Track (e.g. essential documents) and report (e. Safety Reports)
- Ensure the collation and distribution of study tools and documents
- Update clinical trial databases (CTMS) and trackers
- Clinical supply & non-clinical supply management, in collaboration with other country roles
- Manage Labeling requirements and coordinate/sign translation change requests, in collaboration with other country roles (if applicable)
Document management:
- Prepare documents and correspondence
- Collate, distribute/ship, and archive clinical documents, e. eTMF
- Assist with eTMF reconciliation
- Execute eTMF Quality Control Plan
- Update manuals/documents (e.g., patient diaries, instructions)
- Document proper destruction of clinical supplies.
- Prepare Investigator trial file binders
- Obtain translations of documents
Regulatory & Site Start-Up responsibilities:
- Provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
- Obtain, track and update study insurance certificates
- Support preparation of submission package for IRB/ERC and support regulatory agencies’ submissions.
- Publish study results for GCTO and RA where required per local legislation
Meeting Planning:
- Organize meetings (create & track study memos/letters/protocols)
- Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)
Quality & Oversight:
- Contribute strongly to CTC team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement, and providing training as appropriate/required.
- Mentors/buddies junior CTCs (including, but not limited to process requirements)
- Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Hands-on knowledge of Good Documentation Practices
- Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills are required.
- ICH-GCP Knowledge appropriate to the role
- Excellent negotiation skills for CTCs in the finance area
- Highly effective time management, organizational and interpersonal skills, conflict management
- Effective communication with external customers (e.g. sites and investigators)
- High sense of accountability/urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
- Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
- Demonstrates commitment to Customer focus, both internally and externally.
- Able to work independently taking full ownership of delegated tasks
- Proactive attitude to solving problems / proposing solutions
- Positive mindset, growth mindset
- Contributes to CTC team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required.
Qualification & Experience:
- Minimum 3 years in the capacity of Clinical Trial Coordinator within a CRO
- Bachelor’s Degree.
Demzyportal Category: Job Vacancies
