Open Position: Clinical Research Assistant

The Paris Transplant Group in Paris, France, is seeking a research assistant for our research program. This program conducts databases and other clinical researches in solid organ transplant patients.

​The assistant will work under the supervision of the PTG team leader (PI) and project manager to fulfil research-related responsibilities in a professional and ethical manner. The assistant will work with a team of research staff, administrative staff, physicians, nurses and liaise with other healthcare professionals to ensure that each project is conducted to meet the deadlines. This position requires contact with physicians, nurses, pharmacists, and other hospital staff. Strong communication and interpersonal skills are essential.

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Work Performed

• Reports to the team leader and project manager
• Recognize and maintain confidential information
• Ensure that all aspects of study are performed within Good Clinical Practice (GCP)
• Ensure compliance with institutional Standard Operating Procedures (SOPs)
• Review, become knowledgeable about, and adhere to clinical research protocols
• Develop informed consent forms in consultation with PI, project manager, sponsor and ethics board
• Help the project manager to prepare regulatory submissions
• Correspond with PI, sponsors, ethics board, regulatory agencies as needed and document all correspondence in a clear, concise and timely fashion
• Maintain trial related documents in regulatory/study binder ensuring accuracy and completeness, including but not limited to source documentation, case report forms, certifications, screening logs, and drug accountability logs
• Develop excellent study specific work files and document information precisely
• Organize and prepare charts/case report forms/remote data entry for study monitor visits
• Conduct daily aspects of the trials according to defined study protocols
• Communicate study procedures to clinical and research personnel, and provide updates and support to other staff when required
• Work with administrative staff to ensure each study is conducted efficiently and in a fiscally responsible manner
• Coordinate with radiology, laboratory, pharmacy, health records, and nursing as needed by specific protocols
• Prepare for and participate in sponsor site visits, regular monitoring visits and study conference calls
• Report adverse events promptly and accurately as specified in study protocol
• Ensure appropriate study close-out, including archiving and document storage and security
• Participate in consenting, enrollment, and participants' study follow-up calls
• Conduct study questionnaires and performs assessments, review medical charts for past medical history and current medications
• Perform data entry in a timely and accurate manner
• Provide administrative support including filing, directing phone calls, updating tracking logs and maintaining trial regulatory documents
• Prepare and organize materials (eg. documents, lab kits) for ongoing patient follow up study visits
• Organize, prioritize and respond appropriately to incoming correspondence
• Prepare documents, blood samples and other materials for proper handling and shipping
• Work effectively with research coordinators and manager to ensure effective and efficient study conduct
• Perform other research tasks and provides research support as directed

Education/Experience

• Medical terminology course/training is an asset
• Working knowledge of Microsoft Office software (Word, Excel and Power point) required. Excellent organizational, communication and interpersonal skills
• Must demonstrate sound judgment, critical thinking, logical decision making
• Must possess strong problem solving skills, able to anticipate and resolve problems in a timely, effective, ethical, professional, and constructive manner
• Must show strong negotiation, conflict resolution and rapport-building skills.
• Demonstrated ability to take initiative and work in a team environment as well as independently with minimal supervision
• Ability to be flexible, multitask and work well under pressure in a fast paced environment
• Ability to effectively work on multiple simultaneous projects and successfully prioritize to meet deadlines
• Self-directed, highly self-motivated, assertive, enthusiastic and honest in the performance of all duties
• Ability to work in a professional and ethical manner in accordance with hospital policies and procedures, and GCP guidelines
• Must maintain competency in regulatory and institutional requirements to conduct clinical studies in human subjects (e.g. GCP guidelines and regulations)
• Willingness to further professional knowledge through informal (e.g. reading journals/books) and formal education (e.g. attending rounds, conferences, training programs)

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