In-house CRA I/ In-house CRA II

📋 Description

• • Join Precision for Medicine as an In-house CRA I/ In-house CRA II, a pivotal role supporting clinical research studies from a remote location in France.
• • This position is designed for a dedicated professional who will provide comprehensive support to both study sites and clinical project teams, ensuring the smooth and compliant execution of clinical research.
• • You will be instrumental in upholding the integrity of our research by adhering strictly to applicable protocols, Standard Operating Procedures (SOPs), and all relevant regulatory requirements, including International Council for Harmonization (ICH) - Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country-specific regulations.
• • As a key point of contact for study sites, you will foster strong relationships and facilitate effective communication, addressing queries and providing necessary guidance.
• • The In-house CRA I/ In-house CRA II is expected to be a proactive and reliable team member, consistently executing core responsibilities across multiple studies with a high degree of independent judgment and critical thinking.
• • You will operate with minimal supervision, even when tackling complex activities, demonstrating a strong capacity for self-management and problem-solving.
• • A significant aspect of your role will involve assisting with investigator recruitment activities, utilizing provided tools such as phone scripts, questionnaires, and study site materials to effectively evaluate potential investigative sites.
• • You may also play a role in identifying suitable study sites by performing feasibility and recruitment tasks, including the completion, distribution, and review of responses to site recruitment questionnaires.
• • Scheduling and coordinating internal and external meetings as required will be part of your responsibilities, ensuring efficient collaboration among team members and stakeholders.
• • You will be responsible for preparing Investigator Site Files, including their distribution to study sites (electronically or physically) and coordinating with shipping vendors when necessary.
• • A core function involves the ongoing collection, review, maintenance, and close-out of essential documents. You will meticulously organize and maintain site-level data within the Trial Master File (TMF) under general supervision, ensuring sponsor and investigator obligations are met and are in full compliance with ICH/GCP guidelines and applicable local regulations.
• • You will assist in setting up and maintaining site-related data in applicable clinical systems, strictly following established procedures and guidelines.
• • A key tool you will utilize is the Clinical Trial Management System (CTMS) to accurately track study milestones and activities, ensuring project timelines are met.
• • You will serve as a primary contact and liaison for study and site management issues, addressing site questions, assisting with the management of study supplies, and potentially supporting offsite central monitoring activities.
• • Proactive identification and escalation of issues and risks to the appropriate project team members will be crucial for timely resolution.
• • Ensuring timely and complete data entry by study sites into the Electronic Data Capture (EDC) system or any other required data entry system is a critical responsibility.
• • You will be responsible for sending out communications such as email blasts, newsletters, important updates, and updated study core documents to study site personnel.
• • Assistance with logistics support in sample management and tracking, where applicable, and in study supply management will be required.
• • You will support investigators and investigative staff in fulfilling their obligations regarding local submissions, ensuring compliance with local regulatory and Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements.
• • You will assist in data review processes, including the review of site-level data, evaluation of resolutions provided by sites to queries, and facilitating database closure and freezing procedures as per study plans.
• • Continuous support for study tracking via the CTMS, study-specific trackers, or sponsor-designated systems will be necessary to ensure that study reporting remains current, accurate, and complete.
• • Documenting all site and sponsor interactions in a timely, professional, and comprehensive manner is essential for maintaining clear records.
• • You may be involved in the remote review of the electronic Investigator Site File, where applicable, contributing to efficient document management.
• • Assistance with Investigational Product accountability, where applicable, will be part of your duties.
• • You will consult with project team members to address and resolve study site issues, fostering a collaborative problem-solving approach.
• • Providing quality review of amended site-level informed consent templates ensures accuracy and compliance.
• • Following up with sites for trial invoices and ensuring the CTMS is accurately updated will facilitate the timely processing of Investigator Payments.
• • You 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 applicable regulatory requirements and guidelines.
• • In this role, you may also serve as an Independent Essential Document Reviewer post-Site Initiation Visit (SIV).
• • Support for on-site visit activities may be required as needed.
• • For more experienced individuals, there may be an opportunity to mentor an In-house CRA Trainee (New Graduate Level), contributing to the development of junior team members.
• • You will perform other duties as assigned by management, demonstrating flexibility and a willingness to contribute wherever needed.
• • All tasks must be performed in strict accordance with applicable guidelines (e.g., ICH-GCP), company and sponsor SOPs, project plans, study-specific processes, and local regulatory requirements, underscoring a commitment to quality and compliance.