Minnnesota Bioscience Jobs

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Cardiovascular Systems, Inc. Sr. Clinical Research Associate in St. Paul, Minnesota

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Job Summary:

The Sr. CRA assists in the planning, development and execution of clinical research studies under only general supervision, in accordance with applicable global regulatory requirements and company policy. This role may serve as the lead for a designated study or manage a group of research sites, developing and maintaining successful working relationships with internal and external partners, defining and implementing project scope, deliverables, risk mitigation strategies and issue resolution. The Sr. CRA ensures compliance to the study protocol and proactively drives progress to activation, enrollment and data quality milestones by leveraging study and site-level metrics. The candidate must possess strategic thinking, effective communication and data-driven leadership.

Essential Duties and Responsibilities:

  • Coordinates all phases of a clinical study from study development to execution of final results, analysis and interpretation

  • Contributes to the writing, review, and/or editing of sections of key study documents such as protocols, informed consents, study tools, case report forms (CRF), study reports and assists in coordinating processes required for final approval

  • Develops project plans, independently manages study timelines and ensures activities are conducted to achieve goals

  • Uses metrics and leading indicators to identify study risks and engages team in proactive mitigations

  • May create or manage study budget, support monthly accrual activity and quarterly site payments, review invoices and ensure payments are made according to active contracts (if applicable)

  • Manages deliverables and provides feedback to study consultants/contractors, contract research organizations (CROs), biostatisticians, independent core laboratories, clinical/medical experts, data analysts, etc.

  • Prepares and conducts site visits as needed, including site qualification, study initiation, interim monitoring, and close-out visits

  • Effectively and professionally interacts with Primary Investigators, Research Coordinators, and other site staff to ensure efficient site management throughout the study

  • Manages forecasting of study devices, if required, and oversees accountability/reconciliation

  • Supports the planning and conduct of investigator/study meetings

  • Provides ongoing review of site submitted data, documentation and other study requirements, per protocol

  • Provides support or leadership of study committees (CEC, DMC, Publication, Steering) or work groups

  • Prepares and assists in regulatory reports and submissions (if applicable)

  • Continually monitors study compliance and implements corrective action plans at individual sites and across study, as needed

  • Ensures the study is “audit ready” at all times (study team training records, trial master file, etc.)

  • May provide oversight of Contract Research Organizations (CROs) and consultants (if applicable) to ensure that specified scope of work is being performed accurately and according to approved study plans

  • Issues proactive updates regarding the status and progress of the study to the study team and senior management

Knowledge, Skills, and Abilities Required for Successful Job Performance:

  • Bachelor’s degree in biology, physical sciences, nursing or other related field

  • Minimum of six years of experience as a CRA supporting or leading projects through all phases of the clinical study lifecycle (or a minimum of four years clinical experience with a Master’s degree in a related field)

  • Medical/Science Background – Basic knowledge of cardiovascular and peripheral vascular anatomy, percutaneous/endovascular devices and techniques and/or current interventional practices and procedures

  • Medical Device – Strong knowledge of global regulations governing conduct of clinical trials. IDE/pre-market study experience, Japan and/or Outside of the US (OUS) experience desired.

  • Demonstrated ability to work independently and generate solutions to a wide range of difficult issues

  • Demonstrated proficiency with study metrics to inform decisions and actions

  • Strong history of results-driven achievements with the ability to align a team to complete project milestones on time and within scope and budget

  • Excellent interpersonal and communication skills necessary to interact with internal and external personnel

  • Process improvement experience

  • Strong organizational skills and attention to detail

  • Ability to handle multiple and shifting priorities in a fast-paced environment

  • Proficient in Microsoft Office, Word, and Power Point and clinical database management software (e.g. Clindex)

    Specifications/Other

  • Working Conditions:

  • Physical Abilities - must be able to lift 20 lbs

  • Mental Abilities – ability to view computer screen 8 hours per day

  • Travel up to 35% domestically and internationally with extended overnight stays

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