Clinical Trial Coordinator

9 months ago


Midrand, South Africa MSD Full time

**Brief Description of Position**:
Our Clinical Research Team is currently looking for a new **_Clinical Trial Coordinator (Vendor & Ancillary Supply Management). _**

Under the oversight of the line-manager, 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, as applicable.
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. And the person collaborates with finance/budgeting representatives to manage CTRAs and payments.

**Responsibilities include, but are not limited to**:

- **Trial and site administration**:

- Track (e.g., essential documents) and report (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, in collaboration with other country roles (if applicable)
- **Document management**:

- Prepare documents and correspondence
- Collate, distribute/ship, and archive clinical documents, e.g. 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: Collaborate with other country roles to**:

- 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, control, update and close-out country and site budgets (including Split site budget)
- Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
- Track and report contract negotiations
- Update and maintain contract templates (in cooperation with Legal Department)
- Calculate and execute payments (to investigators, vendors, grants)
- Ensure adherence to financial and compliance procedures
- Monitor and track adherence and disclosures
- Maintain tracking tools
- Obtain and process FCPA documentation in a timely manner
- **Meeting Planning**:

- Organize meetings (create & track study memos/letters/protocols)
- Support local investigator meetings

**Qualifications, Skills and Experience**:
**Skills**:

- 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
- Excellent negotiation skills for CTCs in finance area
- 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
- Proactive attitude to solving problems / proposing solutions
- Positive mindset, growth mindset

**Qualification & Experience**:

- Completed job training (office management, administration, finance, health care preferred) or Bachelor’s Degree

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

**Who we are**

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions an



  • Midrand, South Africa MSD Full time

    Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The Clinical Trial Coordinator supports clinical supply and non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as...


  • Midrand, South Africa MSD Full time

    Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The Clinical Trial Coordinator supports clinical supply and non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as...


  • Midrand, South Africa MSD Full time

    **Are you passionate about healthcare and innovation? Do you have a detail-oriented mindset and a desire to make a difference in people's lives? If so, we invite you to join us as a Senior Clinical Trial Coordinator. This vital role in our research & development division allows you to contribute directly to our premier mission of delivering innovative health...


  • Midrand, South Africa MSD Full time

    **Brief Description of Position**: Under the oversight of the line-manager, 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,...


  • Midrand, South Africa MSD Full time

    **Brief Description of Position**: Under the oversight of the line-manager, 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,...


  • Midrand, South Africa MSD Full time

    This role is accountable for performance and compliance for assigned protocols in South Africa and Other African Countries in compliance with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the COM lead, Head COMs or CRD, you...


  • Midrand, South Africa MSD Full time

    Join our team as a Senior Clinical Trial Coordinator (Safety Reporting) and be part of our mission to deliver innovative health solutions. This role is critical in ensuring comprehensive trial and site administration, primarily focusing on safety reporting. You will have the opportunity to collaborate closely with various teams and contribute to continuous...


  • Midrand, South Africa MSD Full time

    This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/Good Clinical Practice and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. Clinical Operations Manager, Head COMs or...


  • Midrand, South Africa MSD Full time

    This role is accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, our Company's policies and procedures and with quality standards internally and externally. The person has ownership, oversight and impact on study operational activities and for out-tasking as applicable....


  • Midrand, South Africa MSD Full time

    This role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. For certain studies, the Clinical Research Manager could be...


  • Midrand, South Africa MSD Full time

    **Brief Description of Position**: This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, the...


  • Midrand, South Africa MSD Full time

    This role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. For certain studies, the Clinical Research Manager could be...


  • Midrand, South Africa MSD Full time

    This role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. For certain studies, the Clinical Research Manager could be...


  • Midrand, South Africa MSD Full time

    **Brief Description of Position**: This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, the...


  • Midrand, South Africa MSD Full time

    With support of other Clinical Research Managers and/or Therapeutic Area Head/Clinical Research Director, this role is accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting...


  • Midrand, South Africa MSD Full time

    Join our cutting-edge Clinical Research team that is dedicated to enhancing global healthcare through groundbreaking research and innovation. As the **Executive Director of Clinical Research**, you will spearhead Clinical Operations in **South Africa and the Sub-Saharan Cluster**, overseeing the execution of all clinical trials within the region. You will...


  • Midrand, South Africa MSD Full time

    With support of Senior Clinical Research Associate/Clinical Research Associate and/or CRA Manager, the Associate CRA acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. Primary Responsibilities: - Develops strong site relationships and ensures continuity of site...


  • Midrand, South Africa MSD Full time

    This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the Clinical Research Director (CRD) the person is responsible to manage a team of 6-14 CRAs and to ensure excellent study and site performance with strict adherence to local regulations, company SOPs and ICH GCP. As line manager the role is critical to...


  • Midrand, South Africa MSD Full time

    The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA Manager, the person ensures compliance of study conduct with Good Clinical Practice and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and...


  • Midrand, South Africa MSD Full time

    **Brief Description of Position**: This role is accountable for performance and compliance for assigned protocols in **SOUTH AFRICA and OTHER AFRICAN COUNTRIES** in compliance with ICH/GCP and country regulations, our Company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight...