Senior Clinical Research Associate
Boehringer Ingelheim
- Fulton, MO
- Permanent
- Full-time
- Responsible for appropriate quality of study protocols, raw data, and reports.
- Ensures all study/trial data are accurate, complete and verifiable from source documents (e.g., as subject research records, medical charts etc.) and regulatory documents.
- Responsible for protocol adherence and ensuring study documentation is completely and properly maintained in accordance with Sponsor protocol, BIVI SOPs, GCP/GLP/ VICH requirements and FDA regulations.
- Ensures deviations are identified and reported to the appropriate Study personnel.
- Responsible for quality control audits of data entry and statistical reports.
- Makes certain that all documents related to in-house, CRO, and field studies are accurate 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 are not limited to, study notebooks, study reports, protocols, study checklists, and analytical data.
- Responsible for identifying qualified CROs/FT Investigators.
- Conducts Investigation Site Visits to evaluate qualifications of the site, Investigator, and research staff.
- Conducts pre-study, ongoing, and study close-out monitoring visits complying with Guidelines for all study/trial sites.
- Verifies both individual subject and overall drug accountability.
- Monitors the progress of in-house studies, field studies, and contract laboratory clinical studies, and provides status reports on progression and quality of the animal or report writing phases of the study.
- Identifies problems with enrollment and mitigations to resolve the issues.
- Drafts protocols, amendments, deviations, and reports and can act as Investigator for in-house or outsourced studies.
- Monitors Adverse Event (AE) reporting and request primary and follow-up information.
- Provides 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).
- Prepares protocols, data, reports, and other documents for submission to regulatory agencies.
- Collaborates closely with Regulatory Affairs to align on document organization.
- Collaborates with the Scientist and study team in protocol development, CRF design, writing amendments, creating site-training materials, final study report, training materials, etc.
- Assists Scientist in planning and implementation of investigator meetings and/or webinars.
- Responsible for the creation and implementation of the study project plan including creating and monitoring timelines for deliverables under the oversight of the Clinical Scientist.
- Assists Scientist with budget development, budget management, and Investigator contract management.
- Assists Scientist in monitoring study trends (e.g., AE trends) and enrollment timelines to meet or exceed project team timelines and goals in line with the TPP.
- Develops and implements improvements for data collection and data processing.
- Recommends revisions to improve effectiveness of monitoring tools, study documents and study processes.
- Bachelor's degree (prefer relevant disciplines such as biology, animal science, nutrition, etc.); MS preferred.
- Minimum of three to five (3-5) years' experience as a CRA/Monitor or similar role.
- 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 up to 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.
- Must understand and implement VICH GCP regulations; GLP is a plus.
- Certification from a recognized clinical research organization (e.g., ACRP or DIA) is preferred.
- 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.