- According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the
- Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.
- Ensures allocated tasks are performed on time, within budget and to a highquality standard. Proactively communicates any risks to project
- Supports the maintenance of study specific documentation and systems including but not limited to: study team lists, tracking of project
- Provides system support (i.e. GoBalto & eTMF).
- Supports RBM activities.
- Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as
- Supports scheduling of client and/or internal meetings.
- Reviews and tracks local regulatory documents.
- Transmits documents to client and centralized IRB/IEC.
- Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
- Maintains vendor trackers.
- Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and nonclinical study
- Assists with studyspecific translation materials and translation QC upon request.
- Ability to work in a team or independently as required
- Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
- Demonstrated ability to effectively analyze projectspecific data/systems to ensure accuracy and efficiency
- Strong customer focus
- Flexibility to reprioritize workload to meet changing project timelines
- Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and
- Good English language and grammar skills and proficient local language skills as needed
- Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial
- Ability to successfully complete PPD clinical training program
- Selfmotivated, positive attitude and good interpersonal skills
-
Clinical Trial Coordinator
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Parexel REMOTE, México RemoteThe 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). ...
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Clinical Study Team Assistant I
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Parexel REMOTE, México RemoteParexel is looking for multiple Clinical Study Team Assistant I in Mexico · 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, Goo ...
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Thermo Fisher Scientific Remote, México De jornada completaJob Description · Summarized Purpose: · Supports supply chain for moderate complex global clinical trials. Ensures project/study activities are in · compliance with company and client requirements. May act as a representative and project lead for the · department on less complex ...
Clinical Trial Coordinator II - Remote, México - Thermo Fisher Scientific
![Thermo Fisher Scientific background](https://contents.bebee.com/companies/mx/thermo-fisher-scientific/background-N1VmS.png)
Descripción
Job DescriptionWe 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 global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.As a PPD Clinical Trial Coordinator you will provide administrative and technical support to the Project Team.
You will support audit readiness by ensuring files are reviewed on schedule detailed in the organization's WPD and department guidance document.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team.We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
Summarized Purpose:
provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed on schedule
detailed in the organization's WPD and department guidance document.
Essential Functions:
team members.
Education and Experience:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification. Bachelor's degree preferred.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be
considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
Working Environment:
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment
where they can thrive.
Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable
manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
May require travel. (Recruiter will provide more details.)