Clinical Trial Coord

hace 7 meses

Ciudad de 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 part of TFS — 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 life-saving 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.

At PPD part of TFS 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.

As a PPD part of TFS 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.

Summarized Purpose:
Provides administrative and technical support to the Project Team. Coordinates responsibilities of project administration as applicable to the client contract under the direction of the assigned Project Lead.

Responsibilities include, but are not limited to
- Reviews regulatory documents for proper content
- Performs study investigator file reviews and logging of outstanding issues in project related tracking tools
- Liaises with monitor and investigative sites to resolve outstanding regulatory issues identified
- Disseminates study related information, including project tracking updates to Clients, clinical study teams and other PPD/TFS departments
- Assists Project Leads and Functional Leads with execution/facilitation of crucial tasks and deliverables to expedite resolution and/or updates
- Provides tracking of training matrices, sop lists and completion adherence and requirements
- Attends high profile conference calls with Clients and provides sufficient response to inquiries

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:

- 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 project-specific 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 organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout
- 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 database systems
- Ability to successfully complete PPD clinical training program
- Self-motivated, positive attitude and good interpersonal skills

Working Environment:
PPD part of TFS 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.)

PPD/TFS 4i Values:

- **Integrity** **- **Innovation** **- **Intensity** **- **Involvement**

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