Clinical Trial Coordinator

2 weeks ago


Centurion, South Africa IQVIA Full time

**ASSIGNMENT PROFILE**
**Clinical Trial Coordinator (CTC)**
**Description of Roles and Responsibilities**
- **Trial and site administration**:

- Tracking (e.g. essential documents) and reporting (e.g. 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 other country roles
- Manage Labeling requirements and coordinate/sign translation change request
**Document management**:

- Prepare documents and correspondence
- Collate, distribute/ship, and archive clinical documents
- Assist with eTMF reconciliation
- Updating manuals/documents (e.g., patient diaries, instructions)
- Document proper destruction of clinical supplies.
- Prepare Investigator trial file binders
- Execute eTMF Quality Control Plan
- Obtain translations of documents
- **Regulatory & Site Start-Up responsibilities**:

- In a timely manner, 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
- **Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives for**:

- Develop country and site budgets (including Split site budget)
- Tracking, and reporting of negotiations
- Maintenance of tracking tools
- Contract development, negotiation, approval and maintenance (e.g. CTRAs)
- Update and maintain contract templates (in cooperation with Legal Department)
- Payment calculation and execution (investigators, vendors, grants)
- Ensure compliance with financial procedures
- Monitor and track adherence and disclosures,
- Budget closeout.
- **Meeting Planning**:

- Organize meetings (create & track study memos/letters/protocols)
- Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

**Experience Required**
Minimum 1-2 years in Clinical Research or relevant healthcare experience
Note - Specific experience requirements may vary depending on the Country
CRA R CTC Role Profile 07-Jun-2017

**Educational Requirements**
B.A./B.S. (Life Science preferred) or equivalent healthcare experience
CORE Competency Expectations
- 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
- ICH-GCP Knowledge appropriate to role

Behavioural Competency Expectations
- 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.
- Able to work independently
- Proactive attitude to solving problems / proposing solutions



  • Centurion, Gauteng, South Africa IQVIA Argentina Full time

    ASSIGNMENT PROFILEClinical Trial Coordinator (CTC)Description of Roles and ResponsibilitiesTrial and site administration:Tracking (e.g., essential documents) and reporting (e.g., Safety Reports)Ensure collation and distribution of study tools and documentsUpdate clinical trial databases (CTMS) and trackersClinical supply & non-clinical supply management, in...


  • Centurion, South Africa Labcorp Full time

    Labcorp is looking to recruit a SCTA (CTC) to join our sponsor in South Africa! **Responsibilities**: **TRIAL AND SITE ADMINISTRATION**: - Tracking (e.g. essential documents) and reporting (e.g. Safety Reports) - Ensure collation and distribution of study tools and documents o Update clinical trial databases (CTMS) and trackers - Clinical supply &...


  • Centurion, South Africa IQVIA Full time

    **Essential Functions** - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines. - Assist the clinical team with the preparation, handling, distribution,...


  • Centurion, South Africa Novasyte Full time

    Job Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical...


  • Centurion, Gauteng, South Africa Oximio Full time

    Oximio is a dynamic pharmaceutical company seeking a highly skilled Clinical Trials Manager to join its team in South Africa. The successful candidate will be responsible for ensuring the safety, quality, and compliance of all imported clinical trial products, adhering to Good Distribution Practice (GDP) and regulatory requirements.About the CompanyOximio is...

  • Sr Clin Trials Asst

    3 weeks ago


    Centurion, South Africa IQVIA Full time

    **Job Overview** Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining...


  • Centurion, Gauteng, South Africa IQVIA Full time

    IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We are seeking an experienced Regulatory and Start Up Manager to join our team.The successful candidate will be responsible for directing and managing the delivery of all required site activation, maintenance, and...


  • Centurion, South Africa Labcorp Full time

    We are looking to hire a Clinical Trials Administrator to work in our office in Johannesburg. **Responsibilities **will include: - Reception management: answering and transferring incoming phone calls, receiving daily post mail and courier parcels. Greeting guests and making sure conference rooms are prepared for the visit. Being the point of contact for...


  • Centurion, Gauteng, South Africa IQVIA Full time

    Job Summary:We are seeking a skilled Clinical Data Associate to join our team at IQVIA. As a Clinical Data Associate, you will play a critical role in ensuring the success of our clinical trials by providing high-quality data management support.Key Responsibilities:Manage data from various sources, including clinical trials and external vendors.Ensure data...

  • Biostatistician

    2 weeks ago


    Centurion, South Africa FHI Clinical Inc Full time

    **Summary of The Position**: The Biostatistician will be responsible for biostatistical aspects, as applicable, of clinical projects undertaken by FHI Clinical, in accordance with the relevant protocol and other trial-related documentation, ICH GCP (and applicable local adaptations thereof), other local legal requirements, relevant FDA, EMA, and other...

  • Clinical Data Manager

    2 weeks ago


    Centurion, South Africa DFNet Research Full time

    **Clinical Data Manager** **South Africa | Remote** - DFnet provides data management, biostatistics, and software development services for industry, non-profit, and academic organizations worldwide. Since 2004, DFnet’s people, products, and services have helped our global clients with over 100 Phase I through Phase IV clinical trials. Our focus is global...

  • Clinical Team Lead

    1 week ago


    Centurion, South Africa Labcorp Full time

    We are currently looking for a Clinical Team Lead to join the team of our global Pharma client. The role is part-time (0.5 FTE) and permanent. **Main responsibilities will include**: 1.Responsible for the overall adequacy of conduct, data quality, compliance and adherence to timelines for their assigned trial(s). 2. Interface with corporate CTOMs, CRA...


  • Centurion, Gauteng, South Africa IQVIA Full time

    Job Description:This role is responsible for providing data management support, oversight, and accountability for one or more clinical trials. The successful candidate will have experience in managing clinical trial data, including creating and tracking content, format, quality, and timing of data management deliverables.Key Responsibilities:Establish data...


  • Centurion, Gauteng, South Africa Oximio Full time

    Job DescriptionOximio is seeking a highly organized and detail-oriented Project Specialist to oversee warehouse operations. The ideal candidate will ensure accurate inventory management, coordinate shipments, and maintain compliance with GDP and ISO standards.The successful candidate will be responsible for maintaining accurate inventory levels, ensuring...


  • Centurion, Gauteng, South Africa IQVIA Full time

    About This Opportunity:We are looking for a highly skilled Data Oversight Specialist to join our team. As a Data Oversight Specialist, you will play a key role in ensuring the quality and integrity of clinical trial data. Your responsibilities will include developing and implementing data management strategies, leading the creation and tracking of data...


  • Centurion, Gauteng, South Africa IQVIA Full time

    Base level rolePerform comprehensive data management tasks including data review, query generation and query resolution. This may also include, but is not limited to creation of eCRF completion guidelines, entry of test data for eCRF and the Data Review Model, testing of data validation rules, etc. Data Management tasks should be inclusive of Study Start-up,...


  • Centurion, Gauteng, South Africa IQVIA Full time

    Our CompanyIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.Job SummaryThe Clinical Data Coder will manage single and multi-service projects, ensuring quality deliverables on time, within budget and to the customer's satisfaction.Key...


  • Centurion, Gauteng, South Africa IQVIA Argentina Full time

    Career OpportunityWe are seeking a talented and experienced professional to join our team as Senior Clinical Data Coder. This role offers a unique opportunity to lead our Clinical Data Management (CDM) team and provide expert skills in coding and data management. As a member of our team, you will be responsible for managing single and multi-service projects,...


  • Centurion, South Africa IQVIA Full time

    You will perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. The role may also include maintenance activities. This is not a line management position but requires...


  • Centurion, Gauteng, South Africa Oximio Full time

    Job SummaryOximio is looking for a Warehouse Operations Specialist to join our team. The successful candidate will be responsible for managing the day-to-day activities of our warehouse operations, including receiving and dispatching goods, maintaining accurate inventory levels, and coordinating with transportation providers.Key Responsibilities:Receive and...