Description

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.

The Clinical Research Associate (CRA) 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 incumbent is responsible for ensuring quality of study protocols, raw data, and reports to support registrations and other claims related to veterinary products. The CRA performs these duties for on-site and off-site (national and global) clinical studies and trials for all animal species.

Duties for this role include interaction with CROs/Investigators, monitoring of study status, quality control and integrity of data, management of study data and performing procedures in compliance to GxP and relevant regulatory guidelines. The CRA also circulates documents for approval, drafts study documents and reports, assists with study in-life phase, designs and implements study related processes, and is responsible for the closure of studies including preparation of archiving.

Duties & Responsibilities

• 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 not limited to, study notebooks, study reports, protocols, study checklists, and analytical data.
• Identification of qualified CROs/FT Investigators.
• Conduct Investigation Site Visits to evaluate qualifications of the site, Investigator, and research staff.
• Conduct pre-study and ongoing monitoring visits in compliance with Guidelines for all study/trial sites.
• Monitors the progress of in-house studies, field studies, and contract laboratory clinical studies, providing status reports in progression of the animal or report writing phases of the study.
• Verifies both individual subject and overall drug accountability.
• Identifies problems with enrollment and mitigations to resolve the issues.
• Collaborates with the Clinical Scientist and Study/Trial team in protocol development, CRF design, writing amendments, creating site-training materials, final study report, training materials, etc.
• Assists Scientists in planning and implementation of investigator meetings and/or webinars.
• 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.

Responsible for:

• Appropriate quality of study protocols, raw data and reports.
• All study/trial data are accurate, complete and verifiable from source documents (e.g., as subject research records, medical charts etc.) and regulatory documents.
• Protocol adherence and study documentation is completely and properly maintained in accordance with Sponsor protocol, BIVI SOPs, GCP/GLP/ VICH requirements and FDA regulations.
• Deviations are identified and reported to the appropriate Study personnel.
• Quality control audits of data entry and statistical reports.

Requirements

• Good verbal and written communication skills (correspondence, protocols, reports, etc.)
• Good interpersonal skills.
• Collaborative team player.
• Possesses a customer service orientation, delivering results and executing in a fast and focused manner.
• Solid organizational skills with a quality orientation.
• Strives for business process excellence.
• Effective time management.
• High degree of attention to detail.
• Ability to find errors or inconsistencies others may miss.
• Exhibits integrity and trust.
• Willingness to travel up to 60% of time.
• English: Fluent (read, write and speak).

CRA:

• Bachelor’s degree (prefer relevant disciplines such as biology, animal science, nutrition, etc.) with one (1) year of experience focusing on clinical studies or two-plus (2+) years’ experience in Human Pharma or Animal Health Research areas.

SR CRA:

• Bachelor’s degree (prefer relevant disciplines such as biology, animal science, nutrition, etc.); MS preferred.
• Minimum of 3-5 years’ experience as a CRA/Monitor or similar role

Eligibility Requirements:

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.