[Remote] Clinical Research Associate/SR CRA
Note: The job is a remote job and is open to candidates in USA. Boehringer Ingelheim is a global leader in the pharmaceutical industry, dedicated to the discovery and delivery of innovative products. They are seeking a Clinical Research Associate/SR CRA to ensure the accuracy and compliance of clinical studies and trials, collaborating with various stakeholders to manage study data and documentation effectively.
Responsibilities
ā¢ 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
ā¢ Documents to be audited include, but not limited to, study notebooks, study reports, protocols, study checklists, and analytical data
ā¢ Identification of qualified CROs/FT Investigators
ā¢ Conduct Investigation Site Visits to evaluate qualifications of the site, Investigator, and research staff
ā¢ Conduct pre-study and ongoing monitoring visits in compliance with Guidelines for all study/trial sites
ā¢ Monitors the progress of in-house studies, field studies, and contract laboratory clinical studies, providing status reports in progression of the animal or report writing phases of the study
ā¢ Verifies both individual subject and overall drug accountability
ā¢ Identifies problems with enrollment and mitigations to resolve the issues
ā¢ Collaborates with the Clinical Scientist and Study/Trial team in protocol development, CRF design, writing amendments, creating site-training materials, final study report, training materials, etc
ā¢ Assists Scientists in planning and implementation of investigator meetings and/or webinars
ā¢ Monitors Adverse Event (AE) reporting and request primary and follow-up information
ā¢ Provides information to pharmacovigilance and RA according to the study protocol and SOPs
ā¢ Ensures availability of all final study documentation for audits/inspections (internal compliance or CVM)
ā¢ Prepares protocols, data, reports, and other documents for submission to regulatory agencies
ā¢ Collaborates closely with Regulatory Affairs to align on document organization
ā¢ Appropriate quality of study protocols, raw data and reports
ā¢ All study/trial data are accurate, complete and verifiable from source documents (e.g., as subject research records, medical charts etc.) and regulatory documents
ā¢ Protocol adherence and study documentation is completely and properly maintained in accordance with Sponsor protocol, BIVI SOPs, GCP/GLP/ VICH requirements and FDA regulations
ā¢ Deviations are identified and reported to the appropriate Study personnel
ā¢ Quality control audits of data entry and statistical reports
Skills
ā¢ Good verbal and written communication skills (correspondence, protocols, reports, etc.)
ā¢ Good interpersonal skills
ā¢ Collaborative team player
ā¢ Possesses a customer service orientation, delivering results and executing in a fast and focused manner
ā¢ Solid organizational skills with a quality orientation
ā¢ Strives for business process excellence
ā¢ Effective time management
ā¢ High degree of attention to detail
ā¢ Ability to find errors or inconsistencies others may miss
ā¢ Exhibits integrity and trust
ā¢ Willingness to travel up to 60% of time
ā¢ English: Fluent (read, write and speak)
ā¢ Bachelor's degree (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' experience in Human Pharma or Animal Health Research areas
ā¢ Must be legally authorized to work in the United States without restriction
ā¢ Must be willing to take a drug test and post-offer physical (if required)
ā¢ Must be 18 years of age or older
ā¢ + Bachelor's degree (prefer relevant disciplines such as biology, animal science, nutrition, etc.); MS preferred
ā¢ + Minimum of 3-5 years' experience as a CRA/Monitor or similar role
Company Overview
ā¢ Boehringer Ingelheim is a group of pharmaceutical companies that focuses on prescription medicines and animal health. It is a sub-organization of Boehringer Ingelheim. It was founded in 1885, and is headquartered in Ingelheim Am Rhein, Rheinland-Pfalz, DEU, with a workforce of 10001+ employees. Its website is https://www.boehringer-ingelheim.com/.
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Responsibilities
ā¢ 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
ā¢ Documents to be audited include, but not limited to, study notebooks, study reports, protocols, study checklists, and analytical data
ā¢ Identification of qualified CROs/FT Investigators
ā¢ Conduct Investigation Site Visits to evaluate qualifications of the site, Investigator, and research staff
ā¢ Conduct pre-study and ongoing monitoring visits in compliance with Guidelines for all study/trial sites
ā¢ Monitors the progress of in-house studies, field studies, and contract laboratory clinical studies, providing status reports in progression of the animal or report writing phases of the study
ā¢ Verifies both individual subject and overall drug accountability
ā¢ Identifies problems with enrollment and mitigations to resolve the issues
ā¢ Collaborates with the Clinical Scientist and Study/Trial team in protocol development, CRF design, writing amendments, creating site-training materials, final study report, training materials, etc
ā¢ Assists Scientists in planning and implementation of investigator meetings and/or webinars
ā¢ Monitors Adverse Event (AE) reporting and request primary and follow-up information
ā¢ Provides information to pharmacovigilance and RA according to the study protocol and SOPs
ā¢ Ensures availability of all final study documentation for audits/inspections (internal compliance or CVM)
ā¢ Prepares protocols, data, reports, and other documents for submission to regulatory agencies
ā¢ Collaborates closely with Regulatory Affairs to align on document organization
ā¢ Appropriate quality of study protocols, raw data and reports
ā¢ All study/trial data are accurate, complete and verifiable from source documents (e.g., as subject research records, medical charts etc.) and regulatory documents
ā¢ Protocol adherence and study documentation is completely and properly maintained in accordance with Sponsor protocol, BIVI SOPs, GCP/GLP/ VICH requirements and FDA regulations
ā¢ Deviations are identified and reported to the appropriate Study personnel
ā¢ Quality control audits of data entry and statistical reports
Skills
ā¢ Good verbal and written communication skills (correspondence, protocols, reports, etc.)
ā¢ Good interpersonal skills
ā¢ Collaborative team player
ā¢ Possesses a customer service orientation, delivering results and executing in a fast and focused manner
ā¢ Solid organizational skills with a quality orientation
ā¢ Strives for business process excellence
ā¢ Effective time management
ā¢ High degree of attention to detail
ā¢ Ability to find errors or inconsistencies others may miss
ā¢ Exhibits integrity and trust
ā¢ Willingness to travel up to 60% of time
ā¢ English: Fluent (read, write and speak)
ā¢ Bachelor's degree (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' experience in Human Pharma or Animal Health Research areas
ā¢ Must be legally authorized to work in the United States without restriction
ā¢ Must be willing to take a drug test and post-offer physical (if required)
ā¢ Must be 18 years of age or older
ā¢ + Bachelor's degree (prefer relevant disciplines such as biology, animal science, nutrition, etc.); MS preferred
ā¢ + Minimum of 3-5 years' experience as a CRA/Monitor or similar role
Company Overview
ā¢ Boehringer Ingelheim is a group of pharmaceutical companies that focuses on prescription medicines and animal health. It is a sub-organization of Boehringer Ingelheim. It was founded in 1885, and is headquartered in Ingelheim Am Rhein, Rheinland-Pfalz, DEU, with a workforce of 10001+ employees. Its website is https://www.boehringer-ingelheim.com/.
Apply To this Job