Clin Ops Specialist/ Cta (South Africa) Homebased

2+ years

Not Disclosed

South Africa

10 Jan. 22, 2025

Job Description

Job Type: Home Based Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Operations Specialist / Clinical Trial Assistant (CTA)
Location: South Africa (Client-Based / Home-Based)
Job ID: 25001311
Updated: January 20, 2025

Company Overview:

Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We deliver clinical, medical affairs, and commercial insights to meet the challenges of the modern market. Our Clinical Development model prioritizes customers and patients, simplifying and streamlining our work processes to deliver impactful outcomes.

As a global organization, we are passionate about fostering an environment where diversity of thought, backgrounds, and perspectives creates a sense of belonging for all.

Why Syneos Health:

Career Growth: We provide opportunities for development through career progression, training, and peer recognition.
Inclusive Culture: Our Total Self culture promotes authenticity and inclusivity, uniting us across borders and backgrounds.
Diversity of Perspectives: We value diverse perspectives and are committed to creating a collaborative environment where everyone feels they belong.

Position Overview:

The Clinical Operations Specialist (COS) or Clinical Trial Assistant (CTA) will support site management activities, assist with clinical trial documentation, and ensure compliance with study protocols. This role offers a home-based, client-dedicated position with minimal travel.

Key Responsibilities:

Compliance & Operations:
- Perform activities in compliance with Corporate and Clinical Operations Policies, SOPs, and Work Instructions.
- Assist Clinical Monitoring staff with site management, ensuring compliance with protocols, study procedures, and guidelines.
- Serve as a Sponsor representative for assigned sites on clinical studies.
Documentation & Data Management:
- Assist in creating and maintaining Trial Master Files (TMF) and other project files.
- Participate in file audits and ensure documents are properly maintained.
- Track and update clinical and regulatory documents for investigator sites, studies, and project teams.
Logistics & Coordination:
- Manage site-related documentation and correspondence, including shared mailboxes.
- Coordinate the ordering, packaging, shipping, and tracking of site supplies and materials.
- Assist in scheduling and organizing team meetings, preparing meeting minutes and action items.
Case Report Forms (CRF):
- Handle the receipt, tracking, and disposition of CRFs and queries.
Training & Awareness:
- Maintain awareness of clinical research developments by completing all required training.

Qualifications:

Education: High School diploma or equivalent required.
Experience: Previous clinical trial experience is necessary.
Skills:
- Strong communication and interpersonal skills.
- Ability to adapt to new technologies.
- Strong organizational and detail-oriented skills.
Travel: Minimal travel (up to 25%) may be required.

About Syneos Health:

Over the past 5 years, Syneos Health has collaborated with 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products. With over 200 studies conducted across 73,000 sites and more than 675,000 trial patients, we are a leader in the clinical development space.

Additional Information:

The listed tasks and responsibilities are not exhaustive, and additional duties may be assigned at the discretion of the company.
Equivalent experience, skills, and education may be considered in lieu of the qualifications listed.
Syneos Health complies with the Americans with Disabilities Act (ADA) and is committed to providing reasonable accommodations when necessary.

Apply Now: [Application Link]
Join Our Talent Network: Stay connected to future career opportunities.

Syneos Health is an Equal Opportunity Employer. We welcome and encourage applicants from diverse backgrounds and experiences to apply.

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Clin Ops Specialist/ Cta (South Africa) Homebased

Job Description

Company Overview:

Why Syneos Health:

Position Overview:

Key Responsibilities:

Qualifications:

About Syneos Health:

Additional Information:

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