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Description

The Principal Clinical Research Associate will manage a team of Clinical Research Associates (CRA) that assist the Clinical Scientists and line managers in execution and control of Clinical GI internal and external laboratory studies and field trials for vaccines, pharmaceuticals, and biotherapeutics.

The incumbent is responsible for ensuring quality of study protocols, raw data and reports to support registrations and other claims related to veterinary products. This role conducts on-site and in-house monitoring to verify that reported study/trial data are accurate, complete, and verifiable from source documents, and to ensure that the trial is conducted in compliance with the current approved protocol, GCP/ VICH requirements, FDA/CVM Regulations, and BI SOPs. The incumbent supports the study teams with coordinating functions (e. g. initiation and organization), conduct and reporting of on-site and off-site (national and global) clinical studies for all animal species. This includes 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. This role ensures that CRAs activities are conducted in line with Project objectives.

The incumbent and the senior team members work in partnership with the Clinical Scientist to help design, execute, and report clinical studies and may also take the lead in the conduct of clinical studies ensuring the quality and integrity of data, and the proper management of study procedures according to Protocol, GxP, VICH and other regulations applicable.

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

+ Assists in identification and selection of qualified CROs/Field Trial Investigators.

+ Conducts Investigation Site Visits to evaluate adequacy of the site, along with the qualifications of the Investigator and research staff.

+ Conducts pre-study and ongoing monitoring visits complying with Guidelines for all study/trial sites.

Management of CRA team:

+ Manages the team resources to optimize the performance of the clinical teams at the site according to Project objectives within the Clinical function.

+ Manages the team activities to ensure accuracy of the forecast and compliance to the site or project budget.

+ Trains, coaches, encourages, develops, leads, recruits and retains Clinical team members according to Talent Management and creates an environment that promotes agility, accountability, and intrapreneurship.

+ Creates and fosters a culture that supports teamwork and collaboration within the global clinical organization as well as with other functions inside and outside of Animal Health Innovation Division.

+ Ensures functional excellence of Clinical Operations staff through hiring, developing, and retaining key talent.

Management of CRA activities:

+ Collaborates with the Clinical Scientist and Study 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, trainings and/or webinars.

+ Ensures a high level of compliance to Study protocols; solves technical issues and increases efficiency.

+ Assists Clinical Scientist with budget development, budget management, and contract management.

+ Assists Clinical Scientist in monitoring study trends (e.g., AE trends) and enrollment timelines to meet or exceed project team timelines.

+ Coordinates experience sharing and building best practices across teams at other BI clinical sites.

+ Develops and implements improvements for data collection and data processing.

+ Recommends revisions to improve effectiveness of monitoring tools, study documents and study processes.

Requirements

+ Master of Science or equivalent. Professional experience in the field of biology or related field.

+ 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.

+ Ability to work independently.

+ High degree of attention to detail.

+ Ability to find errors or inconsistencies others may miss.

+ Accepts accountability and ownership.

+ Exhibits integrity and trust.

+ Willingness to travel up to 60% of time.

+ English: Fluent (read, write and speak).

+ Minimum of 5 years performing Clinical Research activities.

+ Ability to communicate effectively both orally and in writing in an inter-disciplinary.

+ Must have basic knowledge and experience in clinical medicine with an ability to evaluate data and scientific literature.

+ Must understand and implement VICH GCP regulations; GLP is a plus.

**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.

Desired Skills, Experience and Abilities

**Additional Duties & Responsibilities** :

+ Ensures that CRA activities are fully compliant with Quality Assurance standards (GLP, GCP), Good Scientific Practices, Biosafety and internal policies and procedures.

+ Is actively engaged in the improvement of compliance.

+ Ensures that Health Safety and Environment, Biosafety and Animal Welfare requirements are fully applied.

+ May act as investigator for the conduct of in-house or outsourced studies as required.

+ Identifies problems with enrollment and helps to facilitate resolution.

+ Monitors the progress of in-house studies, field studies, and contract laboratory clinical studies, providing status reports at any stage in progression of the animal or report writing phases of the study.

Assumes CRA’s responsibilities to assist Clinical Scientist in Study Director, Monitor or Investigator roles):

+ Ensures administration of GxP studies (i.e., clinical supplies inventory, storage and disposal; data capture and data entry when needed, data storage; study administration and status reports, draft protocols and reports, grant payments, archiving, etc.)

Responsible for Quality Control of GxP studies:

+ Audits all documents related to in-house, CRO, and field studies for accuracy 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.

AE monitoring and reporting:

+ Ensures timely and appropriate reporting of adverse events by investigators.

+ Monitors Adverse Event (AE) reporting and request primary and follow-up information.

+ Provides requested 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).

GI_US925

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.