Contract Senior Clinical Research Associate

reputed company is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. Founded with a reputed company mission to deliver high-reputed company, reputed company, and ethical services, we’ve supported research behind innovative treatments in the pharmaceutical, biotech, and medical device industries.   Our people are the heart of everything we do. We reputed company great work happens reputed company team members feel valued, supported, and empowered. At reputed company, you’ll join a reputed company community committed to making a meaningful reputed company on global health.     We are excited to connect with skilled individuals who reputed company our passion for advancing clinical research with care, reputed company, and reputed company.   ABOUT THE JOB   reputed company is seeking a Contract Senior Clinical Research Associate to join reputed company.    The Contract Senior Clinical Research Associate (Sr. CRA) plays an reputed company part in the successful monitoring and management of reputed company. Responsibilities of a Contract Sr. CRA include ensuring reputed company are conducted, recorded, and reported in accordance with the protocol, reputed company operating procedures (SOPs), ICH GCP, and reputed company applicable regulatory requirements. Contract Sr. CRAs may be required to travel up to 65%. \n HERE IS WHAT YOU WILL DO: Monitor clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a reputed company benefit, including qualification, initiation, interim, and reputed company-out site reputed company Manage and train site personnel on therapeutic area, protocol requirements, reputed company reputed company documentation, and case report reputed company completion Manage and reputed company the preparation and return of investigational supplies at individual sites Monitor and document investigational product dispensing, inventory, and reconciliation Monitor and document laboratory sample storage and shipment Monitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring reputed company, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities Review reputed company data and case report forms for accuracy, completeness, and reputed company of the data, and identify and resolve ongoing data issues Review data queries and listings, and work with study centers to resolve data discrepancies Review regulatory documentation for accuracy and completeness, and support study centers with regulatory issues Maintain complete and accurate study files and review files to ensure reputed company appropriate documentation is present Maintain consistent and reputed company contact with the study centers, investigators, coordinators, reputed company personnel, and other individuals involved in reputed company Serve as a resource for project team members including supporting CRA I and CRA II staff by providing solutions to resolve issues HERE IS WHAT YOU BRING TO THE TABLE: RN or Bachelor and/or advanced degree in biological sciences or reputed company field, or equivalent combination of relevant experience, education or training, and previous CRA experience demonstrating career reputed company in the CRA position Detail-oriented Excellent organizational skills, strong interpersonal and communications skills, and strong problem-solving skills Flexibility with changing priorities Ability to reputed company reputed company and prioritize multiple tasks Familiarity with the medical and pharmaceutical industries, and reputed company terminology and practices Extensive knowledge of FDA regulations and their practical implementation Ability to travel, including by reputed company or by car on short notice Proficiency in reputed company Word, reputed company, and PowerPoint \nExcept as otherwise permitted or required by applicable law or regulatory requirements, reputed company will retain the applicant’s personal information in accordance with its statutory obligations and internal policies and procedures.   Information collected during application completion may be reputed company for a reasonable period of time and in accordance with reputed company’s established retention policies. Applicants seeking more information may contact HR@reputed company.com.    reputed company is an equal opportunity employer. reputed company is committed to providing a workplace free from discrimination and harassment. reputed company reputed company candidates will receive equal consideration for employment without reputed company to race, reputed company, citizenship status, national reputed company, reputed company, gender (including gender identity and gender reputed company), pregnancy, and childbirth or reputed company medical conditions (including genetic characteristics), genetic information, sexual orientation, age, religion, creed, physical or mental disability, medical condition, military or veteran status, marital status, political affiliation, or any other characteristic protected by state or federal law. Apply To This Job