SR Clinical Research Associate

Description

The Senior Clinical Research Associate (SCRA) conducts in-house and external monitoring to verify that reported data collected in Clinical Lab Studies and Field Trials are accurate, complete, and verifiable from source documents and to ensure that the studies are conducted in compliance with the current approved protocol, GCP/ VICH requirements, FDA/CVM Regulations, and BI SOPs. The SCRA is responsible for ensuring quality of study protocols, raw data, and reports to support registrations and other claims related to veterinary products.

 

The SCRA performs these duties for on-site and off-site (national and global) clinical studies and trials for all animal species and across all product modalities. Duties include interaction with CROs/Investigators, monitoring of study status, quality control and integrity of data, management of study data and procedures in compliance to GxP and relevant regulatory guidelines. The SCRA drafts protocols and reports and can act as a Study Leader for studies. The SCRA is responsible for tracking timelines and deliverables and interfacing with internal collaborators (e.g., clinical trial supply, data management, regulatory affairs, PV). The SCRA acts as a trainer, mentor, and resource to CRAs and Study Coordinators and acts as an expert in data and documentation quality.

 

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities

• Responsible for appropriate quality of study protocols, raw data, and reports.
• Ensures all study/trial data are accurate, complete and verifiable from source documents (e.g., as subject research records, medical charts etc.) and regulatory documents.
• Responsible for protocol adherence and ensuring study documentation is completely and properly maintained in accordance with Sponsor protocol, BIVI SOPs, GCP/GLP/ VICH requirements and FDA regulations.
• Ensures deviations are identified and reported to the appropriate Study personnel.
• Responsible for quality control audits of data entry and statistical reports.
• Makes certain that all documents related to in-house, CRO, and field studies are accurate as to drug dosages, drug accountability, numerical calculations, concurrent medications, clinical signs when compared to clinic records, adverse events, clinical observations, and analytical results.
• Documents to be audited include, but are not limited to, study notebooks, study reports, protocols, study checklists, and analytical data.
• Responsible for identifying qualified CROs/FT Investigators.
• Conducts Investigation Site Visits to evaluate qualifications of the site, Investigator, and research staff.
• Conducts pre-study, ongoing, and study close-out monitoring visits complying with Guidelines for all study/trial sites.
• Verifies both individual subject and overall drug accountability.
• Monitors the progress of in-house studies, field studies, and contract laboratory clinical studies, and provides status reports on progression and quality of the animal or report writing phases of the study.
• Identifies problems with enrollment and mitigations to resolve the issues.
• Drafts protocols, amendments, deviations, and reports and can act as Investigator for in-house or outsourced studies.
• Monitors Adverse Event (AE) reporting and request primary and follow-up information.
• Provides information to pharmacovigilance and RA according to the study protocol and SOPs.
• Ensures availability of all final study documentation for audits/inspections (internal compliance or CVM).
• Prepares protocols, data, reports, and other documents for submission to regulatory agencies.
• Collaborates closely with Regulatory Affairs to align on document organization.
• Collaborates with the Scientist and study team in protocol development, CRF design, writing amendments, creating site-training materials, final study report, training materials, etc.
• Assists Scientist in planning and implementation of investigator meetings and/or webinars.
• Responsible for the creation and implementation of the study project plan including creating and monitoring timelines for deliverables under the oversight of the Clinical Scientist.