In-House CRA II (Mexico)
We’re expanding across Mexico, Brazil, Argentina, Colombia, Chile and Peru, and we’re looking for an experienced In-house CRA II to help build the foundation of this new regional function in LATAM!
The In-house CRA II provides overall support to study sites and clinical project teams engaged in clinical research studies. You will adhere 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), and country/region-specific regulations). Acts as point of contact for study sites.
The In-house CRA ll 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 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 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 visits activities if needed
May mentor an In-house CRA Trainee (New Graduate Level)
Performs other duties as assigned by management
Performs all tasks in accordance with applicable guidelines, (e.g., ICH-GCP), company and sponsor SOPs, project plan, study-specific processes, local regulatory requirements
Qualifications:
Minimum Required:
Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline
Minimum of 2 years of relevant experience
Other required:
High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint)
Customer service demeanor; demonstrate flexibility and teamwork
Ability to focus on detail for extended periods of time, high attention to accuracy
Fluency in English communication, verbally and in writing
Working knowledge of the drug development process
Ability to travel as needed
Preferred:
Solid experience in clinical research or related experience
Excellent organizational skills
Ability to work efficiently in a remote work environment
Competencies:
Good knowledge and utilization of ICH-GCP, Precision SOPs, and regulatory guidance
Demonstrates solid interpersonal skills
Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment
Good written and verbal communication skills and presentation skills
Ability to deliver on commitments
Commitment to performing professionally consistent with Precision Principles
#LI-AG2 #LI-REMOTE