Remote Lead Clinical Research Associate– Perm - $125,000 - $140,000
The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.
An American Company is seeking a Remote Lead Clinical Research Associate
• Acting as primary liaison between the study site staff and Sponsor Company
• Overseeing the study site staff to assess protocol compliance and appropriate data collection including proper handling, storage and shipment of biological samples
• Training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion
• Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues
• Reviewing investigational product accountability, including discrepancy resolution
• Processing or overseeing transmission of study data to sponsor according to protocol-specified timelines
• Reviewing data queries and listings, and working with the study site staff to resolve data discrepancies
• Visit report writing and site correspondence
• Monitoring clinical studies of investigational and approved products. This may include qualification, initiation, interim monitoring, and close out site visits
• Monitoring studies by reviewing and reporting to the Sponsor on the following: site enrollment and subject status, findings at monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities
• Interacting with project manager (sponsor or other) through formal and informal communications, including providing updates, identifying issues, sharing of information and instructions
• Supervision and guidance of CRAs, CTAs, and external CROs. Conduct co-monitoring, training, and audit visits.
• Creation of visit report templates. Review of completed visit reports
• Visit report writing and site correspondence
• Managing the resource requirements of the project
• Interdepartmental liaison working with regulatory, data management, biostatistics, and clinical groups to develop and maintain clinical plan
• Managing the preparation, collection, and maintenance of trial regulatory documents
• Maintaining study files to ensure all appropriate documentation is present
• Managing, preparing, sending, tracking, and returning investigational supplies at individual sites
• Managing investigational product ordering, packaging, labeling and ongoing inventory
• Managing the reporting of serious adverse events
• Developing study-related documents such as protocols, case report forms, informed consent forms, study binders, standard operating procedures, study guidelines, study management/tracking tools, and monitoring plans
• Preparing contracts with investigators/hospitals, and negotiating budgets and payment schedules
• Planning, preparing for, and giving presentations at investigator meetings
• Development and management of study timelines
• Assisting with medical writing and regulatory submissions, such as interim, final study, and annual progress reports. Developing or updating Investigational Product Brochures. Preparing documentation for regulatory submissions (IND, NDA, BLA, IDE, PMA)
Skills & Requirements
• Detail oriented
• Excellent organizational skills, strong interpersonal and communications skills, and strong problem-solving skills
• Flexibility with changing priorities
• Ability to efficiently perform and prioritize multiple tasks
• Familiarity with medical and pharmaceutical industry, and related terminology and practices
• Extensive knowledge of FDA regulations and their practical implementation
• Willingness to travel
• Computer proficiency in Microsoft Word, Excel, and PowerPoint
EDUCATION AND/OR EXPERIENCE
• RN or Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education, or training and previous CRA experience.
You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.
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Hays is an Equal Opportunity Employer including disability/veteran.
In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570
Drug testing may be required; please contact a recruiter for more information. #1143138