Job Overview
Location
Remote, France
Job Type
Full-time
Category
Other
Date Posted
February 24, 2026
Full Job Description
đź“‹ Description
- • Join Precision Medicine Group as an In-house CRA I/In-house CRA II, a pivotal role supporting clinical research studies from a remote location within France.
- • This position offers a unique opportunity to contribute significantly to the advancement of precision medicine by providing essential support to study sites and clinical project teams.
- • You will be instrumental in ensuring the smooth and compliant execution of clinical research studies, acting as a key liaison and support system.
- • Adhere rigorously to all applicable protocols, Standard Operating Procedures (SOPs), and regulatory requirements, including International Council for Harmonization (ICH) Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country-specific regulations.
- • Serve as the primary point of contact for study sites, addressing inquiries and facilitating communication to ensure study objectives are met efficiently and effectively.
- • As a solid team member, you will consistently execute core responsibilities across multiple studies, utilizing independent judgment and critical thinking to navigate complex situations.
- • Work autonomously as an integral part of the study team, requiring minimal supervision for even the most challenging activities, demonstrating a high level of competence and proactivity.
- • Assist in critical investigator recruitment activities by employing phone scripts, questionnaires, and study site materials to effectively evaluate potential investigative sites.
- • Potentially play a role in identifying suitable study sites through comprehensive feasibility assessments and recruitment tasks, including the completion, distribution, and review of site recruitment questionnaires.
- • Schedule and coordinate internal and external meetings as required, ensuring efficient communication and collaboration among stakeholders.
- • Prepare and manage Investigator Site Files, including their electronic or physical distribution to study sites and coordination with shipping vendors when necessary.
- • Perform ongoing collection, review, and maintenance of essential study documents, ensuring their organization and upkeep within the Trial Master File (TMF) under general supervision.
- • Guarantee that sponsor and investigator obligations are consistently met and remain in full compliance with ICH/GCP guidelines and all applicable local regulations.
- • Assist in the setup and maintenance of site-related data within applicable clinical systems, strictly adhering to established procedures and guidelines.
- • Utilize the Clinical Trial Management System (CTMS) to meticulously track milestones and activities, ensuring data accuracy and completeness for reporting purposes.
- • Act as a vital site contact and liaison for study and site management issues, adeptly addressing questions and assisting with the management of study supplies.
- • Support offsite central monitoring activities, proactively identifying trends and potential issues.
- • Escalate critical issues and risks to the appropriate project team members in a timely and professional manner to ensure swift resolution.
- • Ensure timely and complete data entry by study sites into the Electronic Data Capture (EDC) system or any other designated data entry platform.
- • Disseminate important communications such as email blasts, newsletters, study updates, and revised core study documents to study site personnel.
- • Provide logistical support for sample management and tracking, where applicable, and assist with the management of study supplies.
- • Support investigators and their staff in fulfilling their obligations regarding local regulatory and Institutional Review Board (IRB)/Independent Ethics Committee (IEC) submissions.
- • Assist in comprehensive data review, including site-level data, and facilitate the resolution of queries with sites to ensure database closure and freezing procedures are executed according to study plans.
- • Aid in study tracking via the CTMS, study-specific trackers, or sponsor-designated systems to maintain current, accurate, and complete study reporting.
- • Document all site and sponsor interactions and study communications in a timely, detailed, and professional manner.
- • Participate in the remote review of electronic Investigator Site Files, where applicable, ensuring data integrity and compliance.
- • Assist with Investigational Product accountability, where applicable, maintaining accurate records and oversight.
- • Consult with project team members to effectively resolve study site issues, fostering a collaborative problem-solving environment.
- • Provide quality review of amended site-level informed consent templates, ensuring accuracy and compliance.
- • Follow up with sites regarding trial invoices and ensure the CTMS is updated accurately to facilitate timely processing of Investigator Payments.
- • May attend site visits as needed, supporting the CRA in ensuring sponsor and investigator obligations related to study documentation are met and are compliant with all applicable regulatory requirements and guidelines.
- • Potentially serve as an Independent Essential Document Reviewer post-Site Initiation Visit (SIV).
- • Support on-site visit activities when required, contributing to the overall success of site operations.
- • May have the opportunity to mentor an In-house CRA Trainee (New Graduate Level), sharing knowledge and fostering professional development.
- • Perform other duties as assigned by management, demonstrating flexibility and a willingness to contribute across various tasks.
- • Execute all tasks in strict accordance with applicable guidelines (e.g., ICH-GCP), company and sponsor SOPs, project plans, study-specific processes, and local regulatory requirements, upholding the highest standards of quality and compliance.
🎯 Requirements
- • Bachelor's degree or international equivalent, or a combination of education and experience in a business, scientific, or healthcare discipline.
- • Minimum of 1 year of relevant experience in clinical research or a related field.
- • High proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).
- • Fluency in both French and English, both verbally and in writing.
🏖️ Benefits
- • Opportunity to work remotely within France.
- • Contribute to groundbreaking work in precision medicine.
- • Professional development and potential mentorship opportunities.
- • Adherence to strict regulatory guidelines ensures a high standard of work.
Skills & Technologies
R
GCP
Remote
Degree Required
About Precision Medicine Group
Precision Medicine Group (PMG) is a leading life sciences consulting firm dedicated to accelerating the development and commercialization of precision medicine. They offer a comprehensive suite of services, including strategy, market access, regulatory affairs, and commercialization support. PMG partners with pharmaceutical, biotechnology, and diagnostic companies to navigate the complex landscape of personalized healthcare. Their expertise spans various therapeutic areas and advanced molecular technologies. By leveraging deep scientific knowledge and market insights, PMG helps clients optimize their drug development pipelines, secure regulatory approvals, and successfully launch innovative therapies. They are committed to advancing patient care through the power of precision medicine, ensuring that the right treatments reach the right patients at the right time.
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