Sr. Clinical Research Monitor/Clinical Research Monitor-AMES

Sr. Clinical Research Monitor/Clinical Research Monitor-AMES


Description:

The Senior Clinical Research Monitor will perform the same duties as the Clinical Res. Monitor with the addition of other clinical duties consisting of, but not limited to, protocol development, planning, implementation , conduct/oversight, clinical study management, study budgets, and some CRO management and reporting. 

For complex multi site (GCP) studies, the incumbent will assume the Lead Monitor role. 

This position will also serve as a resource and mentor to other Clinical Research Monitors, Clinical Research Associates (CRAs) or Study Coordinators. If required, the Sr. Clinical Research Monitor will lead a small group (2-5) of other Monitors, CRAs or Study Coordinators, being accountable for the quality and consistency of the Monitoring/CRA team deliverables.

The Clinical Research Monitor function conducts on-site and in-house monitoring to verify that reported trial data are accurate, complete and verifiable from source documents, and ensure the trial is conducted in compliance with the current approved protocol, GCP/ VICH requirements, FDA/CVM Regulations, and BI SOPs. The Clinical Research Monitor serves as the main liaison for the study sites. 

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 Monitors, CRAs and study coordinators/assistants. Review of and comment on monitoring visits reports completed by co-assigned CRAs or Monitors.
  • Demonstrates leadership competency managing complex multi site studies by being the Lead Monitor.
  • Demonstrates technical ability to initiate and complete all pre-study and ongoing monitoring visits complying with Guidelines for assigned investigational sites. Verify both individual subject and overall drug accountability. Identify problems with enrollment and helps to facilitate resolution. Verify data reported to Sponsor by reviewing all appropriate source documents (e.g., as subject research records, medical charts etc.) and regulatory documents. Endeavor to ensure protocol adherence and study documentation is completely and properly maintained in accordance with Sponsor protocol, BIAH SOPs, GCP/GLP/ VICH requirements and FDA regulations.
  • Independently applies knowledge and expertise to ensure the protocol, SOPs, GCP/ VICH requirements and Regulations are adhered to. Reports deviations and provides the corrective action to the appropriate Study personnel (including Investigator and Study Director).
  • Responsible for the creation and implementation of the study monitoring plan including timelines for study deliverables in collaboration with the Clinical Scientist.  Assist scientist in monitoring study trends (e.g. AE trends) and enrollment timelines in order to meet or exceed project team timelines and goals in line with the TPP.
  • Demonstrates technical and scientific expertise to drive improvements for data monitoring. Recommend revisions to improve effectiveness of monitoring tools, study documents and study processes.
  • Direct contributor in the identification and selection of qualified investigators for Field Studies. Conduct Investigation Site Visits to evaluate adequacy of the site, along with the qualifications of the investigator and research staff. Collect adequate pre-trial documentation.
  • Initiates and completes 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 scientist in planning and implementation of investigator meetings and/or webinars.
  • Directly responsible for 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 FDA)
  • Reports and treats Audits data with high level of integrity and ethics, in adherence to study protocol and regulatory requirements. This includes but not  limited to  accuracy as to drug dosages, numerical calculations, concurrent medications,clinical signs when compared to clinic records, adverse events, clinical observations, and analytical results as it applies to Clinical studies. 
  • Lead Contributor for 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.

Senior Clinical Research Monitor Requirements:

  • Bachelor’s degree from an accredited institution, preferably in a relevant discipline 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.
  • Minimum of three (3) years performing Clinical Research & Development activities with a focus on Monitoring.
  • Demonstrated leadership or mentorship experience (projects or people).
  • Knowledge and proficient use of Microsoft Office Suite Applications and Adobe Standard (pdf formats)
  • In-depth knowledge of animal health research & development.
  • Experience with planning, monitoring, reporting, clinical studies to regulatory authorities.
  • Demonstrated core competency in Clinical Studies with regulatory and compliance requirements.
  • 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
  • In-depth knowledge of local applicable regulatory guidelines (GxP, VICH GL9, and/or 9CFR)
  • Basic knowledge of global regulatory requirements (e.g. CVM, EMA) and compliance.
  • Solid knowledge of medical and pharmaceutical terminology
  • Good interpersonal skills. A collaborative team player.
  • Good verbal and written communication skills (correspondence, protocols, reports, etc.)
  • 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.
  • Ability to communicate effectively both orally and in writing in an inter-disciplinary
  • Able to effectively work in an international and cross-functional matrix environment
  • Understanding of specific softwares (e.g. data bases).
  • Familiarity with electronic data collection (EDC) is preferred.
  • English: Fluent (read, write and speak).
  • Willingness to travel 60% of time.

Clinical Research Monitor Requirements:

  • Bachelor’s degree from an accredited institution, preferably relevant disciplines such as biology, animal science, nutrition, etc., with one (1) year of experience focusing on clinical studies or two (2+) years of experience in Human Pharma or Animal Health Research areas.
  • Able to effectively work in an international and cross-functional matrix environment.
  • Knowledge of local applicable regulatory guidelines (GCP, VICH GL9, and/or FDA).
  • Knowledge and proficient use of Microsoft Office Suite Applications and Adobe Standard (pdf formats).
  • Knowledge of medical and pharmaceutical terminology.
  • 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 is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race; 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.

 

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