Clinical Research Associate II

New Hope, MN

Perm Salary

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as Clinical Research Associate II in New Hope, MN. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity

RESPONSIBILITIES

  • Assist in the planning and execution of clinical studies ensuring that deliverables are completed on time and within budget
  • Create and manage reports that detail the clinical study progress such as subject screening and enrollment, data collection, documentation of adverse events, and payments
  • Assist with the development and management of study-related documents and materials such as investigational plans, case report forms, study manuals, monitoring plan, informed consents, websites, recruitment materials and other study related tools
  • Participate in site qualification and site initiation process, including review of required site documentation
  • Conduct training of investigators and coordinators
  • Coordinate and conduct monitoring visits at investigative sites to ensure compliance to the investigational plans, regulations, and timely receipt of data, including source document verification, device accountability, and writing of monitoring visit reports
  • Verify appropriate reporting and documentation of adverse events and protocol deviations per investigational plan requirements
  • Management of investigative sites to ensure sponsor support of trial activities and oversight of site compliance
  • Assist with the development and implementation of site corrective actions as needed to address any noncompliance issues
  • Assist in planning, preparing, and presenting materials for investigator and coordinator meetings
  • Assist with vendor management to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of work
  • Participate in regular project team meetings
  • Develop and maintain current working knowledge of the disease state & product
  • May assist clinical manager by providing input to sections of clinical reports for FDA (510(K), IDE/PMA) and abstracts/manuscripts

EXPERIENCE

  • Minimum of 2+ years’ experience directly supporting Clinical Research
  • Previous experience with EDC systems preferred

EDUCATION

  • BA/BS or equivalent medical / industry experience

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.  
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource. 

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately

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