PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.
PPD’s Clinical Management department is committed to industry leadership and the relentless pursuit of excellence. Working in the Clinical Management department, you will combine deep knowledge, therapeutic expertise, and robust tools to help our clients deliver life-changing therapies to market.
As a Clinical Trial Coordinator, you will provide technical and administrative support to your assigned clinical project team. You work with a high attention to detail, reviewing documentation, coordinating project details, and maintaining data systems - all with a sense of urgency aligned with that of our customers.
Grow within the Clinical Management department into senior-level Clinical Trial Coordinator roles or leadership roles within the department. Or, develop into Remote Site Monitor or Clinical Research Associate roles. You can also explore opportunities within other groups, such as Site and Patient Access.
The basic purpose of the CTC is to provide technical support to the project team. Will coordinate non-clinical responsibilities of project administration as applicable to the client contract under the direction of the assigned Clinical Manager or Sr. Clinical Manager.
Responsibilities include, but are not limited to;
Assist in the day to day support of study operations including tracking and creating overviews of subject, site, study status, milestones and performing quality check activities across components of the clinical study.
Assist in study set-up including but not limited to eCRF design, protol preparation, informed consents, investigator selection, systems (e.g., CTMS, IVR, etc.), study related operational manuals, trainng materials, and various study plans (e.g., visit logs, drug inventory, monitoring plan, etc.)
Process and track clinical trial materials requests, study related supply requests, safety letters, vendor and investigator payments and other study related activities as needed
Assist in the management of study completion activities including data review and clinical study report review
Ensure complete and timely collection and archiving of TMF documents of assigned studies or program, including oversight and . or submission of regulatory docuemtns tot eh TMF and ongoing document reconciliation.
Assist in maintaining accurate and up to date study information within CTMS and other relevant tracking systems
Effectively communicate with study team members and work closely with Lead Study Manager to address challenges
May participate in process improvement and quality-related initiatives associated with study execution and deliverables
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk - our award winning training programs speak for themselves.
To learn how PPD can advance your career, apply now!
What To Expect Next
We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.
Must have at least 2 years previous experience in the healthcare or related field
Knowledge, Skills and Abilities:
Excellent communication and interpersonal skills
Excellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
Ability to effectively analyze project specific data/systems to ensure accuracy and efficiency
Flexibility to reprioritize workload to meet changing project timelines
Responsible for adhering to FDA Good Clinical Practices, FDA regulations, PPD/Client Standard Operating Procedures and Working Practice Documents regulations for all non-clinical/clinical aspects of project implementation, execution, and closeout
Must have excellent interpersonal, written, verbal, presentation administrative and computer skills.
Fluent in English (oral and written)
Excellent computer skills, proficient in MS Word, Excel, PowerPoint and ability to obtain knowledge and master all clinical trial database systems
Ability to successfully complete PPD clinical training program (CAFT- Clinical Administration Foundation Training)
Ability to mentor and train new Clinical Trial Coordinators as needed
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)