In-House CRA II/ Senior In-House CRA

Precision for Medicine is not your typical CRO. At Precision for Medicine, we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences.

Currently we are looking for In-House CRA II/ Senior In-House CRA in Poland! 

Position Summary:

The In-House CRA II/ Senior In-house CRA 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 Harmonisation (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 II/ The Senior In-house CRA has broad experience and typically handles complex and advanced assignments. Individual is expected to work independently in providing support to CRA and sites. Senior In-house CRA can have increased focus on training and development of junior staff members and can act as Lead In-house CRA.

Essential functions of the job included but not limited to:

• Assists 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) ensuring that sponsor and investigator obligations are being met and are compliant with ICH/GCP guidelines and applicable local regulations.
• Assist with sets up 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 tracking, where applicable and in study supply management.
• Supports investigators and investigative staff in fulfilling obligations regarding local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements.
• Assists in data review inclusive of site level data review, resolutions provided by sites to queries, facilitates database closure and freezing procedures as per study plans.
• Assist with study tracking via the CTMS, Study specific trackers or Sponsor designated system to ensure that the study reporting is current, accurate and complete.
• Documents site and Sponsor contact and study interactions in a timely and professional manner.
• Assist in remote review of the electronical Investigator Site File, where applicable.
• Assists with, or if needed, conducts Investigational Product accountability, where applicable.
• Consults with project team members regarding study site issues.
• Provides quality review of the amended site level informed consent template.
• Follows up with sites for trial invoices and ensures the CTMS is accurately updated to allow the timely processing of Investigator Payments.
• May attend site visits as needed, supporting the CRA to ensure sponsor and investigator obligations related to the study documentation are being met and are compliant with applicable regulatory requirements and guidelines.
• May serve as an Independent Essential Document Reviewer post-SIV.
• Supports on-site visit activities if needed.
• Provides training and mentoring to less-experienced team members and lead multiple In-house CRAs on a project.
• Assists management with the development of training materials