Principal In-house CRA (LATAM)

We’re expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re looking for an experienced Principal In-house CRA to help build the foundation of this new regional function in LATAM!

The Principal 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), and country/region-specific regulations). Acting as point of contact for study sites.

The Principal In-house CRA has extensive site management experience which included experience and knowledge across different type of projects. The Principal In-house CRA is responsible for providing senior oversight and act as subject matter expert in site management activities. Acting as resource for Clinical Monitoring management team support and mentoring and developing others in the team.

Essential functions of the job included but not limited to:

• Performs and manages investigator recruitment activities and assists with development of tools such as phone scripts, questionnaires, study site materials and other tools for use in evaluating investigative sites in partnership with study team
• 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 team leadership, training, and assessment/ coaching feedback to in-house CRA team members
• Leads multiple in-house CRAs on a project, providing training and mentoring as required
• Assists management with the development of training materials
• Assists project team with the development of study specific documents and procedures
• May support manager and interface with partner departments to support enhanced project delivery
• Participates in the creation and maintenance of clinical project documents including, but not limited to Clinical Monitoring Plans, Monitoring Visit Letter templates and Site Start-up Plans consulting with the CTM/SUL
• May act or directly assist functional team lead in supporting sponsors (may have direct client interaction) clinical budget management, vendor support/management and evaluation of metrics to identify process improvements
• May create and execute risk management strategies for their aspect of project delivery with oversight from functional team leads/functional managers
• 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
• 6 years of clinical trial or related 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
• In-depth knowledge of the drug development process
• Experienced with utilizing CTMS, TMF, and EDC systems
• Ability to travel as needed

Preferred:

• Extensive experience in clinical research or related experience
• Excellent communication and organizational skills are essential
• Ability to work remotely
• Skilled in solving higher level complex problems using knowledge/skills, precedents, and practices
• Can support junior In-House CRA on issues identification and resolution

Competencies:

• In - depth knowledge and utilization of ICH-GCP, Precision SOPs, and regulatory guidance
• Demonstrates strong interpersonal skills and time management skills
• Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment
• Excellent written and verbal communication skills and presentation skills
• Ability to deliver on commitments
• Advanced critical thinking skills
• Good leadership skills
• Commitment to performing professionally consistent with Precision Principles

#LI-AG2 #LI-REMOTE