Fsp Clinical Trial Coordinator I

hace 2 meses

Desde casa, México Thermo Fisher Scientific A tiempo completo

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Office

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive
impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

Discover Impactful Work:
Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. Provides administrative support for site activation activities. Aids the development of the critical path for site activation within assigned projects in support of rapid site activations. Represents CRG personnel. May use local knowledge, organization systems, external site lists and sponsor directives to develop and review site lists that are suitable for the strategic needs of feasibility activities and to provide local input into the site tiering process. May act as a buddy during onboarding phase and provide training to new staff as needed.

**A day in the Life**:

- According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.
- Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
- Ensures allocated tasks are performed on time, within budget and to a high
- quality standard. Proactively communicates any risks to project leads.
- Provides system support (i.e., Activate & eTMF) and ensures system databases are always current.
- Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
- Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
- Assists with coordination, compilation and distribution of Investigator Site File

(ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
- Assists with study-specific translation materials and translation QC upon request.
- Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
- Where applicable, conducts on-site feasibility visits (APAC only).
- May support scheduling of client and/or internal meetings.
- May review and track of local regulatory documents.
- May provide system support (i.e., Activate & eTMF).
- May support RBM activities.
- May support the maintenance of study specific documentation and systems, including, but not limited to, study team lists, tracking of project specific training requirements, system access management and activity plans in appropriate system(s).
- Transmits documents to client and centralized IRB/IEC.
- Maintains vendor trackers.
- Supports start-up team in Regulatory submissions.
- Works directly with sites to obtain documents related to site selection.
- Assists the project team with the preparation of regulatory compliance review packages.
- Provides support as needed to coordinate with internal departments, ensuring site start-tup activities within the site activation critical path are aligned.
- May complete the ‘Site Interest Plan’ in CTMS and collection and delivery of

associated documents from investigators and site personnel.
- Documents in real time all communication, attempts a follow up associated with site contact and survey responses.
- Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked.
- Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Communicate with the team and appropriate clinical personnel regarding site issues and risks.
- Ens

  • Clinical Study Team Assistant I

    hace 5 meses

    Desde casa, México Parexel A tiempo completo

    Parexel is looking for multiple Clinical Study Team Assistant I in Mexico, Argentina or Brazil! The Clinical Study Team Assistant I (CSTA I) is an essential part of the study team and is responsible for supporting key clinical trial tasks for assigned studies to ensure compliance with timelines, Good Clinical Practice (GCP), and client Standard Operating...

  • Fsp Clinical Trial Coordinator

    hace 1 mes

    Desde casa, México Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Purpose**: - Clinical Trial Coordinator - Project Specialist is a key member of the Global Study Team contributing to delivering the clinical study to time, cost and quality, and ensuring inspection readiness by taking an oversight over study eTMF completeness. - CTC role was...

  • Clinical Study Team Assistant I

    hace 4 meses

    Desde casa, México Parexel A tiempo completo

    The Clinical Study Team Assistant I (CSTA I) is an essential part of the study team and is responsible for supporting key clinical trial tasks for assigned studies to ensure compliance with timelines, Good Clinical Practice (GCP), and client Standard Operating Procedures (SOPs). The role collaborates with global study team members and is responsible for...

  • Fsp Clinical Trial Coordinator Ii

    hace 2 semanas

    Desde casa, México Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed...

  • Fsp Clinical Trial Coordinator Ii

    hace 2 meses

    Desde casa, México Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Other **Environmental Conditions** Office At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve...

  • Clinical Trial Liaison

    hace 5 meses

    Desde casa, México ICON A tiempo completo

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...

  • Clinical Trial Coordinator

    hace 2 meses

    Desde casa, México Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **CTC-L** We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative...

  • Clinical Trial Coordinator

    hace 5 meses

    Desde casa, México Thermo Fisher Scientific A tiempo completo

    CTC-L **Job Description**: We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost...

  • Clinical Trial Coordinator

    hace 5 meses

    Desde casa, México Thermo Fisher Scientific A tiempo completo

    **CTC-L** **Job Description**: We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and...

  • Clinical Trial Coordinator

    hace 5 meses

    Desde casa, México Thermo Fisher Scientific A tiempo completo

    We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering lifesaving...

  • Clinical Trial Coordinator

    hace 5 meses

    Desde casa, México Thermo Fisher Scientific A tiempo completo

    **CTC-L** We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering...

  • Clinical Trial Assistance

    hace 5 meses

    Desde casa, México IQVIA A tiempo completo

    **Global Clinical Trials Assistant - Home Based role** Location: México City / Monterrey **Services Overview**: Clinical Trial Assistance services provides global support for the Local Trial Manager (LTM)/Trial Manager (TM) and/or Site Manager (SM) or Bus ops CTL&D. **Deliverables**: - Services rendered will adhere to applicable Johnson & Johnson SOPs,...

  • Clinical Study Team Assistant I

    hace 5 meses

    Desde casa, México Parexel A tiempo completo

    Provides study level operational support to the Core Study Team from study start up to close out and submission with general direction: - Management and oversight of Study Team shared spaces - TMF maintenance, compliance, and oversight - Analyze, interpret, and follow up on metrics - Management and oversight of Study Management Platform - Analyze,...

  • Principal Clinical Trial Coordinator

    hace 5 meses

    Desde casa, México Thermo Fisher Scientific A tiempo completo

    We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD —thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering lifesaving...

  • Senior/clinical Data Coordinator

    hace 1 mes

    Desde casa, México IQVIA A tiempo completo

    **Job Overview** The Sr. Clinical Data Coordinator performs activities related to the conduct of Phase I - III clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines. This role ensures that quality work products are produced, and timelines and deliverables are met. **This position can typically be a...

  • Clinical Trial Manager

    hace 2 meses

    Desde casa, México ICON A tiempo completo

    We are currently seeking a Clinical Trial Manager to join our diverse and dynamic team at ICON Plc. In this critical role, you will be responsible for overseeing the planning, execution, and successful completion of clinical trials, ensuring adherence to timelines, budgets, and regulatory guidelines. As a leader in our research department, you will...

  • Clinical Trial Coordinator Ii

    hace 5 meses

    Desde casa, México Thermo Fisher Scientific A tiempo completo

    We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD —locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering lifesaving therapies to patients. Our...

  • Clinical Trial Coordinator Ii

    hace 5 meses

    Desde casa, México Thermo Fisher Scientific A tiempo completo

    We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD —locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering lifesaving therapies to patients. Our...

  • Principal Clinical Trial Coordinator

    hace 5 meses

    Desde casa, México Thermo Fisher Scientific A tiempo completo

    We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD —thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering lifesaving...

  • Clinical Trial Coordinator Ii

    hace 5 meses

    Desde casa, México Thermo Fisher Scientific A tiempo completo

    We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD —locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering lifesaving therapies to patients. Our...