FSP Sr CRA (Cell Therapy)

Work Schedule

Environmental Conditions

Job Description

Join Us as a Senior Clinical Research Associate (Level I) Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 countries in the last 5 years.

As part of our global team youll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Senior Clinical Research Associate (Level I) youll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO FSP Government etc.). Acting as a site processes specialist you will ensure that the trial is conducted in accordance with the approved protocol ICH-GCP guidelines applicable regulations and SOPs to guarantee subjects rights well-being and data reliability.

In this role you will primarily support complex oncology and cell and gene therapy (CGT) studies requiring a strong understanding of advanced therapeutic environments and associated operational challenges. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.

What Youll Do:

Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA) critical thinking and problem-solving skills to identify site process failures and implement corrective/preventive actions to ensure compliance and minimize risks particularly in complex oncology and CGT studies.

Ensures data accuracy through SDR SDV and CRF review as applicable through on-site and remote monitoring activities.

Assesses investigational product (IP) handling storage and accountability including considerations for advanced therapies such as cell and gene therapy (e.g. chain of identity/custody where applicable).

Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution.

Maintains regular contact between monitoring visits with investigative sites to ensure protocol adherence timely data entry and resolution of previously identified issues.

Conducts monitoring tasks in accordance with the approved monitoring plan and supports site compliance in complex study environments.

Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required and ensures study systems are updated per agreed conventions (e.g. CTMS).

Participates in investigator meetings and supports site identification qualification initiation and close-out activities.

Ensures that essential documents are complete and maintained according to ICH-GCP and applicable regulations; conducts on-site file reviews as required.

Contributes to project team deliverables and supports audit and inspection readiness including participation in regulatory inspections where required.

Facilitates effective communication between investigative sites sponsor and project team.

Education and Experience Requirements:

Bachelors degree in a life sciences related field or equivalent

Minimum 35 years of independent clinical monitoring experience

Experience in oncology and/or cell and gene therapy studies is required

Experience managing complex clinical trials (e.g. early phase or advanced therapy studies) is strongly preferred

In some cases a combination of education training and directly related experience may be considered

Knowledge Skills and Abilities:

Strong clinical monitoring skills with experience in complex therapeutic areas

Demonstrated understanding of oncology and/or cell and gene therapy environments

Excellent knowledge and application of ICH-GCP applicable regulations and procedural documents

Strong critical thinking and problem-solving skills including root cause analysis

Experience applying risk-based monitoring (RBM) principles

Effective communication and stakeholder management skills

Strong attention to detail and organizational skills

Ability to work independently and manage multiple priorities

Proficiency in Microsoft Office and clinical systems (e.g. Veeva eTMF CTMS EDC)


Working Conditions and Environment:

This role follows a hybrid working model combining office-based work at PPD and remote work from home.

Frequent travel to investigator sites is required (typically 6080%) including on-site monitoring visits.

May require extended or overnight stays depending on study and site location needs.

Work is performed in office clinical and/or home office environments with exposure to standard office equipment.

Exposure to clinical environments including biological materials and potentially infectious agents may occur; appropriate personal protective equipment (PPE) will be required.

Must be able to comply with sponsor client and site-specific requirements (e.g. access requirements health and safety protocols or other site qualifications).