Job Description

OverviewTitle - Senior Clinical Trial AssistantLocation - Johannesburg South AfricaSponsor dedicatedICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organization's.With our 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.Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.This role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools.The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB/ERC and Health Authorities. The role will collaborate at local level closely with COM, CRM and CRA.The person acts as process Subject Matter Expert (SME), making recommendations for continuous improvement, providing training as appropriate/required and mentoring junior CTCs.ResponsibilitiesResponsibilities include, but are not limited to:Trial and site administration:

• Track (e.g. essential documents) and report (e. Safety Reports)
• Ensure collation and distribution of study tools and documents
• Update clinical trial databases (CTMS) and trackers
• Clinical supply & non-clinical supply management, in collaboration with othercountry roles
• Manage Labeling requirements and coordinate/sign translation change request, 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
• Maintain Investigator Site File(ISF) for studies
• 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)

QualificationsRequirements

• 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, Veeva Vault, eTrack, Oracle) and ability to adapt to new IT applications. Strong MS Excel skills required.
• ICH-GCP Knowledge appropriate to role
• Investigator & Vendor Payment Processing experience an advantage
• Clinical trial budgets and contracts experience an advantage

• 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 or Pharmaceutical company
• Bachelors Degree an advantage

What ICON can offer you:Our success depends on the quality of our people. Thats why weve made it a priority to build a diverse culture that rewards high performance and nurtures talent.In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

• Various annual leave entitlements
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your familys well-being
• Life assurance

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request .Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles.#LI-SB1#LI-Hybrid

ICON