Clinical Trial Coordinator

hace 6 días


Bogota, Colombia MSD A tiempo completo

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.

**Secondary** Language(s) Job Description**:
Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:
1. In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
2. Obtain, track and update study insurance certificates
3. Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
4. Publish study results for GCTO and RA where required per local legislation

Document management:
1. Prepare documents and correspondence
2. Collate, distribute/ship, and archive clinical documents, e.g. eTMF
3. Assist with eTMF reconciliation
4. Execute eTMF Quality Control Plan
5. Update manuals/documents (e.g., patient diaries, instructions)
6. Document proper destruction of clinical supplies.
7. Prepare Investigator trial file binders

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Project Temps (Fixed Term)

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R233572



  • Bogota, Colombia MSD A tiempo completo

    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...


  • Bogota, Colombia MSD A tiempo completo

    **Job Description**: 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...


  • Bogota, Colombia IQVIA A tiempo completo

    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...


  • Bogota, Colombia Icon plc A tiempo completo

    Clinical Trial Manager II JR090304 Site: Peru / Brazil / Chile / Colombia / Mexico ICON 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...


  • Bogota, Colombia Novasyte A tiempo completo

    IQVIA Biotech is committed and dedicated to the small biotech & biopharma companies we support. Opportunities available for an experienced Clinical Trial Manager II or Senior Clinical Trial Manager. Previous clinical trial management and CRO experience preferred. Therapeutic requirements/preference: any of the following Oncology/Hematology/CAR T/Cell &...


  • Bogota, Colombia MSD A tiempo completo

    ¿Estás listo para poner en práctica tus conocimientos, aprender e impactar en millones de vidas? ¡Si es así, esta es la oportunidad perfecta para que hagas parte de una empresa que le apuesta a la innovación, la experimentación y el crecimiento! **Estas son algunas de las funciones que realizarás como practicante de Clinical Trial Operations** -...


  • Bogota, Colombia Insight Therapy Solutions A tiempo completo

    **Clinical Operations Coordinator** **Work set-up**: Remote **About Us** We are a rapidly evolving mental health clinic with a small clinic culture and a tech company vision. We evolved from a traditional physical location to a tech-driven company during the pandemic, but have maintained our warm and collaborative culture. **The role** Seeking a skilled...


  • Bogota, Colombia ICON A tiempo completo

    ICON 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 organizations. With our patients at the center of all that we do, we help to accelerate the development...

  • Clinical Research Manager

    hace 2 semanas


    Bogota, Colombia MSD A tiempo completo

    **Job Description**: This role is primarily accountable for the end-to-end performance and project management for assigned protocols in compliance with country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally. The Clinical Research Manager could be responsible for a particular study...


  • Bogota, Colombia Novasyte A tiempo completo

    Great opportunity if you want to join one of the greatest CROs! Job Overview Perform a variety of administrative tasks in support of clinical trials and assist in the performance of clinical procedures to collect data on patients enrolled and/or seeking enrollment in clinical studies. Essential Functions - Provide clinical research support to...