Sr. Clinical Research Associate/Clinical Research Associate-AMES

Sr. Clinical Research Associate/Clinical Research Associate-AMES


Description:

The Senior Clinical Research Associate (Sr. CRA) is responsible for the execution and control of Clinical R&D study programs in alignment with Clinical Scientists and line managers. In addition, the Sr. CRA may lead other CRAs and Study Coordinators, being accountable for the quality and consistency of the CRA team deliverables or collectively positioning the knowledge and expertise within the study teams. The Sr. CRA is a crucial member of study teams and provides key direction in the initiation, organization, conduct and reporting of on-site and off-site (national and global) clinical studies for all animal species. This comprises 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 incumbent also circulates documents for approval, drafts study documents and reports, assists with study in-life phase, may perform on-site investigator and monitoring of studies, designs and implements study related processes and is responsible for the closure of studies including preparation of archiving.

Senior Clinical Research Associate may take a lead in the conduct of clinical studies to ensure the quality and integrity of data, and the proper management of study procedures according to Protocol, GxP, VICH and other regulations applicable.  The SrCRA works in partnership with the Clinical Scientist to help design, execute, and report clinical studies. The SrCRA may act as a study leader for individual studies with responsibility to track timelines and deliverables as well as interface with internal collaborators (e.g. clinical trial supply, data management, regulatory affairs, PV).

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 a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim’s high regard for our employees. 

Duties & Responsibilities:

  • Provide leadership, orientation, training and mentoring of less experienced and/or recently hired CRA and study coordinators/assistants. Review of and comment on monitoring visit reports completed by co-assigned CRAs.
  • Demonstrates technical and scientific expertise to drive improvements for data collection and data processing. Recommend revisions to improve effectiveness of monitoring tools, study documents and study processes.
  • Collaborates with clinical scientist to provide critical input needed for project success. Such as, budget development and management, and investigator contract management.
  • Proposes, gains support and implements with the clinical scientist alternative ways in monitoring study trends (e.g. AE trends) and enrollment timelines in order to meet or exceed project team timelines.
  • Independently 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. Assist Scientists in planning and implementation of investigator meetings and/or webinars.
  • Responsible for the activities in Submission Preparation: Lead (or participate in) the protocol-specific Clinical Operations submissions sub-team (respectively assigned monitors and senior coordinators) in the preparation of data portions of dossiers to be submitted to regulatory authorities (e.g., CVM). Collaborates effectively with Regulatory Affairs to align on document organization.
  • Initiates and completes routine audits for all documents, aligned with procedures and policies for study program, related to in-house, CRO and field studies for accuracy as to drug dosages, 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: Ensure timely and appropriate reporting of adverse events by investigators. Monitor Adverse Event (AE) reporting and request primary and follow-up information. Provide requested information to pharmacovigilance and RA according to the study protocol and SOPs. Ensure availability of all final study documentation for audits/inspections (internal compliance or CVM)
  • Reports, review and communicates study data entry (as assigned) and performs quality control audits of data entry and statistical reports with high level of integrity and ethics
  • 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. May act as investigator or support in the animal work for the conduct of in-house or outsourced studies as required.
  • Acts as study Leader, if required, for Research Studies and/or take an Investigator role for specific studies depending on the incumbent’s experience and the type of study
  • Collaborates with clinical scientist with budget development, budget management, and investigator contract management. Proposes with the clinical scientist alternative ways in monitoring study trends (e.g. AE trends) and enrollment timelines in order to meet or exceed project team timelines.

Sr. Clinical Research Associate Requirements:

  • Bachelor’s degree from an accredited institution, preferably in a relevant disciplines such as biology, animal science, nutrition, etc., with three to five (3-5) years of experience as a CRA/Monitor or in a similar role.
  • MS is a strong plus.
  • Certification from a recognized clinical research organization (e.g. ACRP or DIA) is preferred.
  • Minimum of three (3) years of experience performing Clinical Research & Development activities.
  • Demonstrated core competency in Clinical Studies with regulatory and compliance requirements.
  • Able to effectively work in an international and cross-functional matrix environment.
  • In-depth knowledge of local applicable regulatory guidelines (GxP, VICH GL9, and/or 9CFR).
  • Knowledge and proficient use of Microsoft Office Suite Applications and Adobe Standard (pdf formats).
  • Demonstrated leadership experience (projects or people).
  • Solid knowledge of medical and pharmaceutical terminology.
  • Solid knowledge of GCP and GLP. Understanding GMP is a plus (depending on site).
  • Felasa C certificate or equivalent (depending on site).
  • Understanding of specific softwares (e.g. data bases).
  • In-depth knowledge of animal health research & development.
  • Basic knowledge of global regulatory requirements (e.g. CVM, EMA) and compliance.
  • Experience with planning, monitoring, reporting, clinical studies to regulatory authorities.
  • Familiarity with electronic data collection (EDC) is preferred.
  • Must understand and implement VICH GCP regulations; GLP is a strong plus
  • Good verbal and written communication skills (correspondence, protocols, reports, etc.)
  • Good interpersonal skills. A 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 60% of time.
  • English: Fluent (read, write and speak)
  • 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.

Clinical Reseach Assoicate Requirements:

  • Bachelor’s degree from an accredited institution (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 of experience in Human Pharma or Animal Health Research areas.
  • Felasa C certificate or equivalent (depending on site).
  • Able to effectively work in an international and cross-functional matrix environment.
  • In-depth knowledge of local applicable regulatory guidelines (GxP, VICH GL9, and/or 9CFR).
  • Knowledge and proficient use of Microsoft Office Suite Applications and Adobe Standard (pdf formats).
  • Knowledge of medical and pharmaceutical terminology.
  • Basic knowledge of GCP is a plus. 
  • Understanding of specific softwares (e.g. data bases).
  • Good verbal and written communication skills (correspondence, protocols, reports, etc.)
  • Good interpersonal skills.
  • A 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 60% of time.
  • English: Fluent (read, write and speak).

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. 

Who We Are: 

At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.

Want to learn more?  Visit boehringer-ingelheim.com and join us in our effort to make more health.

Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA Inc., Boehringer Ingelheim Animal Health Puerto Rico LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; citizenship status, marital, domestic partnership or civil union status; gender, gender identity or expression; affectional or sexual orientation; pregnancy, childbirth or related medical condition; physical or psychiatric disability; veteran or military status; domestic violence victim status; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by applicable federal, state or local law. 

  

Job  Clinical Operations

Primary Location  Americas-US-IA-Ames

Organization  US-Boehringer Ingelheim Animal Health

Schedule  Full-time

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Posted on

December 14, 2020