Principal In-house CRA

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 doc