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Clinical Trials Project Coordinator

2 months ago

Frankfort, Kentucky, United States myGwork - LGBTQ+ professionals & allies Full time
Join Our Team

This inclusive employer is a member of myGwork – the largest global platform for the LGBTQ+ business community.

Work Schedule

Other

Environmental Conditions

Office

Job Overview


Our PPD Laboratory Services team plays a crucial role in enhancing patient health through the expertise of scientists, industry thought-leaders, and therapeutic specialists.

As the leading entity in serving science, our laboratory professionals are dedicated to precision and quality, driving innovative advancements.


Position:
Clinical Trials Project Coordinator

Division/ Department:
Clinical Research Group/ Global Central Labs

Location:
Remote (United States)

Impactful Contributions


Oversees and manages all facets of designated clinical trial protocols within Global Central Labs, ensuring overall project performance and client satisfaction by fulfilling their needs and expectations throughout the lifecycle of assigned clinical trials.

Offers internal consultancy on project management matters and identifies avenues for process and efficiency enhancements. Serves as the primary liaison to the operational teams of major sponsors and is accountable for extensive study programs. Prepares and maintains process documentation and acts as a backup for the (Associate) Director PM when necessary. Mentors Project Managers.

Daily Responsibilities

Coordinates and supervises study initiation. Reviews, interprets, translates, and programs study protocols into a comprehensive and accurate database.

Engages with internal departments and external vendors to ensure project requirements are comprehended, agreed upon, and adhered to consistently.

Facilitates the exchange of technical and clinical laboratory information among all stakeholders (investigational sites, sponsors, and non-technical personnel).

Consults and leverages, where suitable, the scientific insights of laboratory management and technical staff to assist clients in managing clinical trials.

Prepares study specifications documents and ensures their preparation aligns with budgets and contracts. Maintains an updated study master file with version controls for specifications, budgets, and contracts.

Ensures sponsors have authorized and signed off on the most recent versions of all documents and that a contract is in place before delivering any services.

Ensures compliance with FDA and Good Clinical Practice guidelines, PPD SOPs, personnel policies and procedures, PPD Exposure Control Plan, IATA, and other regulations regarding the transport of biological specimens.

During the initial protocol review, consults with internal groups and support staff regarding procedural and budgetary items and the necessity for changes due to any subsequent protocol amendments.

Secures commitment from other functions to address gaps and resolve issues promptly and effectively. Acts as the chief liaison between sponsors and all PPD internal departments executing the required tasks during all study phases. Educates investigator sites by delivering protocol-specific lab procedures presentations and demonstrations during investigator meetings.

Manages and oversees daily activities throughout the clinical trial to resolve any issues and respond to queries.

Actively collaborates with IT and data management development teams in designing, validating, and implementing new software and functionalities relevant to project management activities.

Consults with BD and finance personnel during the initial project documentation review on standard services and costs, supporting RFP feasibility assessments.

Provides advice on potential solutions as needed. Drafts responses for proposals.
Guides and supports the workflow of Project Managers and Set-up Administrators, with a focus on training junior personnel.

Serves as a mentor and trainer for newly assigned Project Managers, identifying areas for development and efficiencies in task execution.

Authors, reviews, revises, and implements pertinent procedural documents. Acts as a backup for the (Associate) Director PM when necessary.

Keys to Success

Education

Bachelor's degree or equivalent and relevant formal academic/vocational qualification.

Experience


Prior experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years) or an equivalent combination of education, training, and experience.

Years of experience refer to typical years of related experience needed to acquire the required knowledge, skills, and abilities necessary to perform the essential functions of the job.

Years of experience should not be the sole determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills, and Abilities

Strong verbal, written, and presentation skills
Exceptional time management, planning, and organizational skills
Proficient with specific computers and enterprise applications, including office productivity tools
Ability to program the IT system according to protocol requirements
Demonstrated analytical skills
Proven compliance with procedures and policies
Ability to manage multiple tasks effectively in a high-pressure environment
Extensive knowledge and experience in Project Management within a Global Central Lab setting
Strong client relationship management skills
Ability to collaborate effectively with multi-level teams

Requirements

PPD values the health and wellbeing of our employees. We support and encourage individuals to cultivate a healthy and balanced environment where they can thrive.

Below are the working environment/requirements for this role:


Able to communicate, receive, and comprehend information and ideas with diverse groups of people in a clear and reasonable manner.

Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology proficiently.
May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.
Able to perform successfully under pressure while prioritizing and managing multiple projects or activities.
May require travel.

Our Mission is to empower our customers to create a healthier, cleaner, and safer world.

As one team of over 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - collaborating to accelerate research, tackle complex scientific challenges, drive technological innovation, and support patients in need.

#StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds, and perspectives are valued.

We are an EEO/Affirmative Action Employer and do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

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