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CRA II/Sr. CRA -- 3555106501 : Clinical Operations RMD

Company: Ascent
Location: Tucson
Posted on: September 13, 2019

Job Description:

Job Req #: 19-08290Job Description: CRA II/Sr. CRALocation: ?Tucson, AZPosition Type: 6-12+ Months?Position Summary: Responsible for the conduct and management of clinical study activities to verify and validate new clinical software, instrument platforms, assays and biomarkers developed by. Works independently to complete CRA functions associated with study planning, implementation, monitoring and closing study conduct in accordance with the principles of Good Clinical Practice (GCP).Key Responsibilities:

  • Works under moderate guidance and participates in the planning and implementation clinical research projects; contributes technical and clinical operations expertise
  • May co-ordinate the activities of relevant colleagues within the Company and investigators to ensure compliance with the overall scientific study objectives. May work with international investigators and key customers as well.
  • Travels to field sites to monitor studies.
  • Under moderate guidance; plans and prepares studies.
  • Reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents
  • Works with Data Management and Biostatistics staff on the design of documents and processes for the collection of study data from participating sites.
  • Collects and maintains legal and regulatory documentation, as applicable.
  • Manages training and coordinating certification of study site personnel.
  • Ensures accurate and complete study management/data collection and transfer to data management.
  • Ensures site compliance with regulations and study protocol.
  • Monitors the sites and provides technical assistance, as necessary.
  • Manages material logistics for the studies.
  • Conducts reference material testing in-house.
  • Organizes investigator meetings, as necessary.
  • May act as a lead for assigned projects and/or Project Team Meetings.
  • Evaluates and escalates decisions impacting project team and/or work area(s) and/or broader organization.
  • Maintains a high level of professional expertise through familiarity with scientific literature, Company product portfolio, and competitive environments.
  • Processes and applies specific knowledge to the completion of difficult work assignments.Qualifications:
    • Bachelor?s degree in scientific discipline or related field required, or equivalent combination of education and work experience.
    • 5+ years of experience in clinical study coordination, clinical site monitoring or clinical study management is required, 7+ preferred.
    • Prior experience with current Good Clinical Practices (cGCP) and Code of Federal Regulations (CFR) is preferred.
    • A background in biomedical/healthcare services with laboratory experience preferred.
    • Excellent skills in basic computer applications (Word, Excel, Access, PowerPoint).
    • Excellent writing and verbal communication skills.
    • Well organized and detail oriented.
    • Impeccable record keeping and filing skills.
    • Excellent time management skills.
    • Ability to give presentations and teach others.
    • Ability to work effectively in a team, and also work independently on assigned tasks
    • Independent monitoring experience (SQV -> COV)*Those authorized to work in the U.S. are encouraged to apply / Unable to Process H1B visa at this time / Unable to work on a C2C basis for this role*??

      Company Description:

      About Ascent:Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascent---s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts.If you are ready to propel your career to new heights--- read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.

Keywords: Ascent, Tucson , CRA II/Sr. CRA -- 3555106501 : Clinical Operations RMD, Healthcare , Tucson, Arizona

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