Clinical Trial Coordinator

hace 2 semanas

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

  • Clinical Trial Coordinator

    hace 2 semanas

    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...

  • Clinical Trial Coordinator

    hace 2 semanas

    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...

  • Clinical Trial Assistant

    hace 2 semanas

    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...

  • Clinical Trial Assistant Global

    hace 4 días

    Bogota, Colombia Novasyte 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...

  • Clinical Trial Manager Ii

    hace 2 semanas

    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...

  • Sr. or Clinical Trial Manager, Oncology, Columbia

    hace 2 semanas

    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 &...

  • Practicante Clinical Trial Operations

    hace 2 semanas

    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** -...

  • Senior Clinical Data Coordinator

    hace 2 semanas

    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 Trial Administrator Ii

    hace 4 días

    Bogota, Colombia PSI CRO A tiempo completo

    Company Description PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. **Job Description**: Join our international team and be the...

  • Field Clinical Specialist Cardio

    hace 4 días

    Bogota, Colombia Boston Scientific Corporation A tiempo completo

    **Field Clinical Specialist Cardio - Bogota**: - Remote Eligible: Field Based- Onsite Location(s): Bogota, CUN, CO**Additional Locations**: N/A **Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of...