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PPD

Clinical Trial Coordinator - Client Dedicated - Collegeville, PA

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 deliveringlife-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 aPPDClinical 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:

Administer, maintain and co-ordinate the logistical aspects of operational support for clinical studies according to ICH GCP, local regulations, relevant company written standards and act as a pivotal point of contact for Country Clinical Operations Staff.

Responsible for assisting local study team in the ongoing feasibility, planning, execution and closeout of the study.

Responsible for workload, related to clinical study conduct, and other general responsibilities for the team.

Essential Functions:

To assist local study teams in coordinating the planning, feasibility, start-up, and management of sites involved in clinical studies within agreed timelines and in accordance with company written standards and ICH GCP.

Able to perform study-related tasks with minimal or no oversight.

Partner with study teams for the accuracy of study systems.

Maintain effective communication and working relationships with internal and external stakeholders.

Provide technical support to US LOC staff. Assist in 1:1 training of staff in the use of study tracking systems.

Collaborates with other internal roles for country feasibility and site selection.

Responsible for being up-to-date on ICH GCP guidelines and company written standard operating procedures and business processes in adherence to companywritten standards and processes. Attend appropriate training sessions. Participate in relevant training courses to improve personal/professional skills.

Participate in projects and initiatives to contribute to the optimization of processes, tools and systems. Serve as SMEs and agents of change to champion process improvement initiatives in the US LOC.

Provide support to study team(s) in the event of an audit from global regulatory agencies and where appropriate, assist with resolution of any actions.

Job Qualification:

Education and Experience:

Bachelor's degree or equivalent experience preferred.

Experience in pharmaceutical industry or health related field

Proficiency in multiple software applications

Comprehensive knowledge of the clinical development process,

FDA regulations & /ICH GCP guidelines

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 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 ideaswith diverse groups of peoplein a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours.

Ability to use and learnstandard office equipment andtechnologywith 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.

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