Clinical Trial Coordinator

PPD Czech Republic, s.r.o.

Place of work
Prague, Czechia
Contract type
full-time
Wage (gross)
From 1 Kč/hourCompetitive

Information about the position

Job description, responsibilities and duties

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 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.

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:

-According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.
-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 high-quality standard. Proactively communicates any risks to project leads.
-Supports 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 tracking of project level activity plans in appropriate system.
-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 assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.
-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 non-clinical study supplies to sites.
-Assists with study-specific translation materials and translation QC upon request.

Job Qualification

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

Employee perks, benefits

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.)  

PPD Defining Principles:
- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD –

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you

Diversity Statement
PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.

Requirements for the employee

Candidates with education suit the position

Follow-up/Higher Professional Education
University education (Bachelor's degree)

Educational Specialization

Clinical Administration

Language skills

English - Advanced (C1) and Czech - Proficiency (C2)

The position is suitable for a fresh graduate

Yes

Personality requirements and skills

Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) obtain knowledge and master all clinical trial database systems

Advertiser

Brief description of the company

PD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our customers and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With more than 30,000 professionals worldwide, PPD has conducted clinical trials in more than 100 countries to help customers deliver life-changing therapies to improve health. We apply innovative technologies, therapeutic expertise and a firm commitment to quality to bend the cost and time curve of drug development and optimize value.

PPD is now part of Thermo Fisher Scientific. As the world leader in serving science, our Mission is to enable our customers to make the world healthier, cleaner and safer. We are excited about the opportunities this combination brings to enhance our comprehensive end-to-end offering, enabling customers to move rapidly from scientific idea to approved medicine.

Number of employees

1000 and more employees
ID: 4213636  Datum zveřejnění: 30.11.2021  Spodní hranice mzdy (brutto): 1 Kč/hour