RWE Sr CRA 1

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Job OverviewPerform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.Essential Functionsu2022 Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.u2022 Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.u2022 Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.u2022 Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.u2022 Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.u2022 Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.u2022 Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.u2022 Collaborate and liaise with study team members for project execution support as appropriate.u2022 If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.u2022 If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.Qualificationsu2022 Bachelor's Degree Degree in scientific discipline or health care preferred. Requ2022 Requires at least 2 years of year of on-site monitoring experience.u2022 Equivalent combination of education, training and experience may be accepted in lieu of degree.u2022 Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.u2022 i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.u2022 Good therapeutic and protocol knowledge as provided in company training.u2022 Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).u2022 Written and verbal communication skills including good command of English language.u2022 Organizational and problem-solving skills.u2022 Effective time and financial management skills.u2022 Ability to establish and maintain effective working relationships with coworkers, managers, and clients.At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at https://jobs.**MEMBERS ONLY**SIGN UP NOW***.comWe are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.****the COVID-19 virus continues to evolve, IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status.****

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