Precision for Medicine is looking for an In-house CRA I/ In-house CRA II in France!
Position Summary:
The In-house CRA I/ In-house CRA II provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH) -Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as point of contact for study sites. The In-house CRA I/ In-house CRA II is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in complex activities.
Essential functions of the job included but not limited to:
- Assist with the investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools for use in evaluating investigative sites.
- May assist in identifying study sites by performing site feasibility and recruitment tasks, e.g., completing, disseminating, and reviewing responses to site recruitment questionnaires.
- Schedules internal and external meetings as required.
- Prepares Investigator Site Files including distribution to study sites (electronically or physically), coordination with shipping vendor, if required.
- Performs ongoing essential document collection and review, maintenance, and close-out activities, organizing and maintaining site level data in the trial master file (TMF) under general supervision ensuring that sponsor and investigator obligations are being met and are compliant with ICH/GCP guidelines and applicable local regulations.
- Assist with set ups and maintains site-related data in applicable clinical systems according to procedures and guidelines. Utilizes the Clinical Trial Management System (CTMS) to ensure milestones and activities are accurately tracked.
- Acts as site contact/liaison for study and site management issues including addressing questions, assists with managing study supplies, and may support offsite central monitoring activities. Escalates issues and risks as needed.
- Ensures timely and complete data entry by site in EDC or any other system that requires data entry.
- Sends email blasts/newsletter, updates, and updated study core documents to study site personnel.
- Assists in providing logistics support in samples management and track