Pr. Clinical Research Associate
This highly experienced Pr. CRA will set the clinical strategy and lead clinical program planning and execution of an exciting and novel technology for CSI. 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 internal and external program 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 program 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.
Essential Duties and Responsibilities:
- Strategically plan and coordinate all phases of a clinical study from development to execution, analysis and interpretation
- Independently develop project plans, manage study timelines and communicate progress with cross-functional stakeholders
- Develop and maintain successful working relationships with study sites and cross functional team members, defining and implementing project scope, deliverables, risk migration strategies, and issue resolution
- Create, review, and/or edit 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
- Prepare and conduct site visits as needed, including site qualification, study initiation, interim monitoring, field partner/site escalations and close-out visits
- Define metrics and leading indicators to predict study risks and engage team in proactive mitigation execution
- Effectively communicate and influence across all levels of the organization
- 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
- Lead regulatory agency discussions and negotiations related to study design, IDE and product approvals
- Own study budget creation, management, reforecasting and accruals
- Forecast investigational study devices, conduct accountability and reconciliation activities
- Plan and initiate investigator/study meetings and lead study committees (CEC, DMC, Publication, Steering), work groups and KOL meetings
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, pre-market/IDE 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.
- 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
- Demonstrated exceptional interpersonal and communication skills necessary to interact with internal and external personnel
- 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)
- Working Conditions:
Physical abilities (must be able to lift 20 lbs)
Mental abilities (view computer screen 8 hours per day)
- We are a fast-growing company with opportunities for growth
- Up to 35% domestic and international travel
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.