Advanced Group

  • In-House CRA

    Job Locations US-IL-Deerfield
    Req No.
    2018-9806
    Type
    Regular Full-Time
    Client
    Advanced Clinical
  • Overview

    Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there’s no better place to grow your career than Advanced Clinical.

     

     

     

     

     

     

    Responsibilities

    Summary of Responsibilities
    An In-house Clinical Research Associate will work closely with the Lead CRA and Clinical Research Associates by providing centralized support to regional team members, assisting with the preparation, organization and follow-up of investigator and study site selection, site communications and clinical monitoring tracking both at a local and international level. This role will involve:
     
    Essential Functions

     

    • Support Site Identification, Recruitment & Qualification
    • Be first line of contact to direct or address non-medical site questions
    • Perform study tracking to ensure that all study files and documents are accurate, current and complete.
    • Perform essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements, ICH/GCP guidelines and SOPs.
    • Provide general support to the Lead CRA and CRA in order to manage the investigator sites and ensure compliance
    • Develop or contribute to newsletters for assigned studies based on information provided by Project Team.
    • Maintain FAQ list for assigned trial(s)
    • Confirm and track that all key site personnel have project specific training.
    • Document site and sponsor contact and study interactions in a timely and professional manner.
    • Assist with resolution of investigational site/data queries.
    • Liaise with project team members regarding study site issues.
    • Provide quality review of the informed consent template
    • Track submission to and approval from IRB, 1572 changes (including obtaining medical licenses and CVs related to these changes) correspondence, site changes.
    • May provide study-specific direction, training and mentoring to CRAs, and support staff as appropriate, and may provide guidance to other team members.
    • Travel to sites and meetings as needed.
    • Other duties as assigned and may change with change in studies/Advanced Clinical needs.  

    Qualifications

    Qualifications

     

    Education: Bachelor’s degree, in biological sciences or healthcare
    Experience: 3+ years related experience. Clinical trial experience level experience (CRO, healthcare settings and industry experience are acceptable). Prefer scientific discipline and multiple therapeutic experiences.
     
    The candidate must have:

    • Excellent verbal and written communications skills; excellent interpersonal and organizational skills with demonstrated attention to detail.
    • Strong computer proficiency in MS Office including Word, Excel, and PowerPoint.
    • Strong critical thinking, problem solving and analytical skill sets.
    • Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines.
    • Excellent organizational and record-keeping skills.
    • Ability to maintain excellent working relationships with a broad range of trial staff.
    • Knowledge of GCP as relates to clinical trial management
    • Ability to work well in a team environment but also independently without significant oversight. Flexibility in work hours and readiness to travel.

    What’s in it for you? Advanced Group offers competitive compensation, comprehensive benefits packages, and a flexible work environment designed to help our team members and their families stay healthy, meet their financial goals, and generally thrive in and beyond work. Visit the links below to discover all that Advanced Group has to offer:

    Our Culture: https://careers.advancedgroup.com/embrace-our-culture

    Career Development Opportunities: https://careers.advancedgroup.com/realize-your-potential

    Community Programs: https://careers.advancedgroup.com/unleash-your-passion

    For a complete list of all of our job openings, please visit Advanced Group’s career site here.

     

    It is Advanced Group’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.


    This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job.  If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

     

    This job description is a summary. It is not intended to be comprehensive in detail. Individuals with this job title will be expected to perform according to their individual goals and evaluations in addition to this job description and all applicable standards (SOPs, manuals, code of conduct, laws, regulations, etc.).

     

    http://www.advancedclinical.com/

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