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Boehringer Ingelheim · 5 hours ago

Clinical Research Associate/SR CRA, Field Trials

Ames, IA

Full-time

Hybrid

Mid, Senior Level

1+ years exp

Boehringer Ingelheim is a global leader in healthcare, and they are seeking a Clinical Research Associate/SR CRA to ensure that clinical studies are conducted in compliance with protocols and regulatory requirements. The role involves monitoring data quality, collaborating with study teams, and managing documentation for veterinary product studies.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

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 not limited to, study notebooks, study reports, protocols, study checklists, and analytical data

Identification of qualified CROs/FT Investigators

Conduct Investigation Site Visits to evaluate qualifications of the site, Investigator, and research staff

Conduct pre-study and ongoing monitoring visits in compliance with Guidelines for all study/trial sites

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

Verifies both individual subject and overall drug accountability

Identifies problems with enrollment and mitigations to resolve the issues

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

Assists Scientists in planning and implementation of investigator meetings and/or webinars

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

Appropriate quality of study protocols, raw data and reports

All study/trial data are accurate, complete and verifiable from source documents (e.g., as subject research records, medical charts etc.) and regulatory documents

Protocol adherence and study documentation is completely and properly maintained in accordance with Sponsor protocol, BIVI SOPs, GCP/GLP/ VICH requirements and FDA regulations

Deviations are identified and reported to the appropriate Study personnel

Quality control audits of data entry and statistical reports

Qualification

Clinical Research ExperienceGCP/VICH ComplianceData ManagementBachelor's DegreeRegulatory SubmissionTrustCustomer Service OrientationFluent in EnglishCommunication SkillsInterpersonal SkillsTeam CollaborationOrganizational SkillsAttention to DetailTime ManagementIntegrity

Required

Good verbal and written communication skills (correspondence, protocols, reports, etc.)

Good interpersonal skills

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 up to 60% of time

English: Fluent (read, write and speak)

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

Bachelor's degree (prefer relevant disciplines such as biology, animal science, nutrition, etc.); MS preferred

Minimum of 3-5 years' experience as a CRA/Monitor or similar role

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

Company

Boehringer Ingelheim

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Boehringer Ingelheim is a group of pharmaceutical companies that focuses on prescription medicines and animal health. It is a sub-organization of Boehringer Ingelheim.

Founded in 1885

Ingelheim Am Rhein, Rheinland-Pfalz, DEU

10001+ employees