Clinical Research Associate

Job Department: Clinical Field InvestigationsJob Category: Biotechnology and PharmaceuticalJob Description:
Boehringer Ingelheim is a family-owned company that is in the business of providing our customers with pharmaceutical and animal health products that significantly enhance their health and improve their quality of life. Our most important resource is our committed, creative and determined employees whose energy is focused on discovery, development and delivery of our innovative products to those who need them. The employees of Boehringer Ingelheim are our most important competitive advantage. Our global presence and thinking provides the opportunity for employees to work internationally and on teams, offering them visibility and the ability to influence the direction and outcome of critical projects. Competitive benefit and compensation programs reflect the Company’s high regard for its employees and enhance each person’s ability to balance the demands of work and personal responsibilities. Every employee at Boehringer Ingelheim contributes to the company’s uncompromising commitment to quality in our products, excellence in our scientific pursuits and high ethical standards of behavior. The diversity of our employees makes it possible for us to craft unique solutions to today’s complex business challenges. We are an equal opportunity employer. M/F/D/V.Duties and Responsibilities:
Assist in the identification and selection of qualified investigators. Conduct pre-investigation Site Visits to evaluate adequacy of the site, along with the qualifications of the investigator and research staff. Collect adequate pre-trial documentation.
Conduct ongoing monitoring visits complying with Monitoring Guidelines and the ISF for assigned investigational sites.
Monitor trial progress with the investigator, site research staff and the Clinical Trial Team.
Review medical records to ensure protocol adherence. Report deviations to the CRA Manager and Clinical Trial Monitor.
Endeavor to ensure protocol adherence and study documentation is completely and properly maintained in accordance with Sponsor protocol, BIPI SOPs, G CP/ICH requirments and FDA regulations..
Ensure proper storage, accountability and disposition of investigational drug.
Initiate personal development plans to enhance product, therapeutic and regulatory knowledge. Continually seek to improve efficiency in order to support multiple therapeutic areas and monitor 15 or more assigned sites.
Ensure proper maintenance of investigator site files at research site and in CTMF.
Endeavor to assure investigator compliance for the reporting of Adverse Events and Serious Adverse Events to BIPI and the IRB.
Provide on-site orientation to investigators and other site personnel.
Participate in Clinical Trial Team meetings as needed. REQUIREMENTS
Requirements:Degree in Life Sciences (BA, BS, Masters,PhD), Degree or Diploma in Nursing (RN), or Pharmacy (R.Ph, or Pharm.D)
Thorough understanding of Good Clinical Practices.
Basic knowledge and experience in clinical medicine with an ability to evaluate data and scientific literature.
2 to 5 years experience reviewing regulatory documents or performing onsite monitoring.Superior planning, organizational, interpersonal, and problem solving skills.
Excellent oral and written communication skills.
Ability to appropriately represent the Company at research sites, work independently, and be an effective team member.