[Remote] Clinical Research Associate/SR CRA

Note The job is a remote job and is open to candidates in USA. reputed company 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

• Makes certain that reputed company documents reputed company to in-house, CRO, and field studies are accurate as to drug dosages, drug accountability, numerical calculations, reputed company medications, clinical signs reputed company 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 reputed company study/trial sites
• Monitors the reputed company 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 reputed company 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
• reputed company study/trial data are accurate, complete and reputed company from reputed company 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 Skills
• 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 reputed company 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
• 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
• + 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 Company Overview
• reputed company is a group of pharmaceutical companies that focuses on prescription medicines and animal health. It is a sub-organization of reputed company. 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.reputed company.com/. Apply To this Job Apply To this Job