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Clinical Site Manager II (CRA II)- Early Phase, Oncology

Company: PAREXEL
Location: Severn
Posted on: March 21, 2020

Job Description:

Parexel has launched a new clinical operating model to drive effectiveness, reduce hand-offs and increase employee, client and site satisfaction. Within this model, the Clinical Site Manager (CSM), formerly the Clinical Research Associate (CRA), serves as the clinical sites' direct point of contact. The CSM role offers the opportunity to go beyond the role of a typical clinical monitor. CSMs are accountable for using their expertise to build and maintain the site relationship and ensure they are set up for success. This includes addressing and resolving site issues and questions. You will also manage site quality and delivery from site identification through to close-out.As a CSM, Parexel will offer you world class technology and training catered to your individual experience. You can anticipate less travel and a lower protocol load in comparison to industry peers. Your hard work will be rewarded through a bonus incentive program, the opportunity to work within multiple therapeutic areas, and an opportunity to advance your career in clinical research. If impact, flexibility, and career development appeal to you, please apply to learn more.Your Key Accountabilities:Act as Parexel's sole contact with assigned clinical sitesUse your trial management expertise to oversee overall integrity of the study and problem-solving skills to promote positive working relationships with the site and staffConduct qualification visits (QV), site initiation visits (SIV) and monitoring visits (MV) at assigned clinical sites; generate visit/contact reportReview the performance of the trial at designated sites, ensuring the rights and well-being of human subjects are protected and are in accordance with protocolEvaluate the quality and integrity of the reported data, site efficacy, and drug accountabilityDevelop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines Ensure compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s)Monitor completeness and quality of Regulatory Documentation and perform site document verificationQualificationsYour Skillset:Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminologyOncology experience requiredKnowledge of or strong Interest in Early Phase monitoring requiredEducated to degree level (biological science, pharmacy or other health related discipline)Demonstrates strong interpersonal, written, and verbal communication skills within a matrixed teamAbility to work in a self-driven capacity, with a sense of urgency and limited need for oversightClient focused approach to work; flexible attitude with respect to work assignments and new learningAbility to manage multiple tasks, to evaluate a variety of unpredictable scenarios, and achieve project timelines; apply understanding of study protocol(s)Work ethically and honestly to promote the development of life changing treatments for patientsStrong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and WordOur Offer:Join the best minds in the industry and leverage your expertise to help advance treatments into the hands of those who need them most. This role is an excellent opportunity to enhance your skills and take the lead on client projects.We look forward to speaking with you and determining how Parexel fits into your career journey!EEO DisclaimerPAREXEL is an equal opportunity employer.-- Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Keywords: PAREXEL, Severn , Clinical Site Manager II (CRA II)- Early Phase, Oncology, Executive , Severn, Maryland

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