Pr. Clinical Research Associate

Clinical St. Paul, Minnesota


Description

Job Summary:

The Pr. CRA sets the direction for clinical studies by independently leading the planning, development and execution of clinical research projects, in accordance with applicable global regulatory requirements and company policy.  This role is empowered to make strategic decisions and influence the clinical study direction with input from scientific and physician advisors and internal cross-functional partners. The Pr. CRA will lead study communications, provide oversight to consultants and vendors (as applicable) and provide work direction to the team while ensuring compliance with all applicable international regulatory requirements, regulations and policies. This position has responsibility for clinical study metrics, milestones and budget with high executive visibility and engagement. As a seasoned clinical professional, this role will serve as a mentor to other clinical colleagues and may advise on other studies or initiatives to advance the success of the overall function. The candidate must possess strategic thinking, strong communication and proactive leadership.

Essential Duties and Responsibilities:

  • Serves as the primary point of contact for a designated study (or studies), developing and maintaining successful working relationships with study sites and cross functional team members, defining and implementing project scope, deliverables, risk mitigation strategies and issue resolution
  • Strategically plans and coordinates all phases of a clinical study from development to execution, analysis and interpretation
  • Creates, reviews, and/or edits sections of key study documents such as protocols, informed consents, study tools, case report forms (CRF), study reports in compliance with applicable regulations and geographic requirements
  • Independently develops project plans, manages study timelines and ensures activities are conducted in order to achieve scheduled milestones and goals
  • Defines metrics and leading indicators to predict study risks and engages team in proactive mitigations
  • Creates and manages study budget, supports monthly accrual activity and quarterly site payments, reviews invoices and ensures payments are made according to active contracts
  • Manages deliverables and provides feedback to study consultants, 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
  • Plans and conducts investigator/study meetings and provides leadership of study committees (CEC, DMC, Publication, Steering) or work groups
  • Provides ongoing review of site submitted data, documentation and other study requirements, per protocol
  • Collaborates with data management, safety, statistics groups as needed to generate required summary reports and analyses; 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, central files, system validation, etc.)
  • Provides 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 ten years of experience leading projects through all phases of the clinical study lifecycle (Masters or Doctorate degree in a related field may apply to years of experience)
  • Must have medical device experience with strong knowledge of cardiovascular and peripheral vascular anatomy, percutaneous/endovascular devices and techniques and/or current interventional practices and procedures
  • Demonstrated knowledge of global regulations governing conduct of clinical trials with experience planning and leading complex, global pre-market trials
  • Demonstrated ability to work without appreciable direction, makes decisions using sound logic, and generates creative solutions to a wide range of very complex issues
  • Demonstrated ability to lead and communicate effectively with various cross-functional teams
  • Demonstrated history of results-driven achievements with the ability to lead a team to complete project milestones on time and within scope and budget
  • Demonstrated ability to influence across all levels of the corporation, including executive level leaders
  • Ability to coordinate multiple tasks (for self and team) and reprioritize based on changing demands in a fast-paced environment.
  • Advanced skills 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
  • Work is performed on-site in an office environment with exposure to electrical office equipment
  • Travel up to 35% domestically and internationally with extended overnight stays

CSI is an EEO/AA company: Women, Minorities, the Disabled and Veterans are encouraged to apply. If you are a job seeker with a disability and require accessibility assistance or reasonable accommodation to apply for an open position, please contact the Recruiting Department at Cardiovascular Systems, Inc., 1225 Old Hwy 8, New Brighton MN 55112, or call (651) 259-1600.