Boehringer Ingelheim Specialist, Clinical Research in FULTON, Missouri
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.
Responsible for providing support and assistance, under the guidance of the Director II / designee, to the Clinical Research & Development (R&D) staff in the execution and control of administrative functions required in Clinical R&D study programs at the Missouri Research Center (MRC). These include auditing of documents, monitoring the status of studies, preparation and auditing of study reports, data entry, data coordination and collation, shipment of test article to clinical study sites, circulation of documents for approval, distribution of approved documents to staff and preparation of study notebooks.
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:
Audits all documents, under the guidance of the Director II / designee, related to on-site studies and contract laboratory clinical studies for accuracy as to drug dosages, numerical calculations, concurrent medications, clinical signs when compared to clinic records, adverse reactions, clinical observations, and analytical results.
Documents to be audited include, but not limited to, study notebooks, study reports, protocols, study checklists, and analytical data.
Participates as a member of the Clinical R&D team by assisting in the origination of the study protocol, conducting pre-study and ongoing study functions including, but not limited to, designing of study report forms, instigating the Notice of Study, notebook preparation, initiating calendar of events, and implementing Research Services Agreements, Statement of Investigators, and Curriculum Vitae for contract laboratories, etc.
Under the guidance of the Director II/designee, evaluates procedures using the Standard Operating Procedures of Pharmaceutical Research & Development to ensure adherence to governmental regulations is maintained for on-site studies and contract laboratory clinical studies.
Monitors the progress of on-site studies and contract laboratory clinical studies and provides status reports at any stage in progression of the animal or report writing phases of the study.
Completes study data entry and performs quality control audits of data entry and statistical reports.
Prepares and audits, under the guidance of the Director II/designee, the study report for on-site studies and outside contract laboratory clinical studies.
Assists the Monitor or Investigator in responding to audits on study data and study reports issued by Quality Assurance or Research Associate auditors.
Functions as on-site quality control auditor, as well as trial coordinator, for studies to be sent to contract quality control auditors for complete audit at the end of the study.
B.S./B.A. degree from an accredited institution with at least one (1) year of clinical trials, pharmaceutical industry or auditing experience –OR- A.S./A.A. degree from an accredited institution with three (3) years clinical trials, pharmaceutical industry or auditing experience.
Prior research experience and knowledge of GCP/GLP regulations would be valuable.
Knowledge and skills with Microsoft Office, Microsoft Word and Excel along with strong organization skills and attention to detail are essential.
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
Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighbourhoods where we live and work. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, 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; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings.
Organization: US-Merial, Inc.
Title: Specialist, Clinical Research
Location: Americas-United States-MO-Fulton
Requisition ID: 187146