Advanced Clinical

  • Clinical Trial Lead - Home Based

    Job Locations US-Nationwide
    Req No.
    2018-9325
    Category
    Biotech/R&D/Science
    Type
    Regular Full-Time
  • 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

    A Clinical Trial Lead  (CTL) is a member of the project team responsible for the execution of the clinical trial(s) at the site level, accountable for development and execution of the clinical monitoring plan (CMP), site identification and selection, CRA and site training, development of CRA and site materials, trackers, and logs necessary to track and document deliverables. The lead CRA will review monitoring visit reports and track actual to projected variables and parameters related to CRA & site activities.   All activities will be in compliance with cGCPs, country specific regulations, ICH Guidelines, and SOPs.

    • Site Identification, Recruitment & Qualification
    • Participate in the qualification of sites, Site Activation, Site maintenance, Site closure
    • Develop study specific templates
    • Develops study specific plan for release of IP
    • Participates in documents requiring translation and the process for their translation
    • Develop ICF template
    • Oversee projection of planned site activation and SIVs
    • Develop contents of investigator site file, site operations manual and pharmacy manual
    • Reviews visit reports and F/U letter
    • Review and prepare weekly status reports
    • Establish study milestones and ensures accurate tracking and reporting of study metrics.
    • Provide input and manage clinical trial budgets and staffing/resourcing plans.
    • Ensure that clinical trials are conducted in accordance with country’s regulations, Good Clinical Practice regulations, and internal Standard Operating Procedures. 
    • May provide study-specific direction, training and mentoring to CRAs, and support staff as appropriate, and may provide guidance to other team members.
    • Participate in clinical operations initiatives and programs as assigned. 
    • Client faced in day to day operations
    • Participates in bid-defense meetings, kick off meetings, and investigator meetings. 
    • Travel to sites and meetings as needed
    • Other duties as assigned and may change with change in studies/Advanced Clinical needs

    Qualifications


    Education: Bachelor’s degree, in biological sciences, healthcare, or pharmacy medicine preferred
    Experience:  5+ years related experience. CRA level experience (both CRO 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.

     

    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.

     

     

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