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Clinical Research Associate

Employer
Cardiovascular Systems Inc
Location
Saint Paul
Salary
Competitive

View more

Industry
Education
Role
Other
Job Type
Long-Term
Hours
Full Time
Putting a new spin on your career

Working at CSI means being a part of something greater than ourselves. We think big and move fast. From creating revolutionary technologies, to working with world class physicians and teams, we don't simply work, we save lives. We have big company drive and small company vibe where your daily impact can be felt company-wide. If you are curious, ambitious and dedicated, you will love our community. Grow with us!

Job Summary:

The Clinical Research Associate (CRA) is a member of the Clinical Affairs team and is responsible for supporting the planning, development and execution of global clinical research studies, in accordance with applicable regulatory requirements and company policy. This position is the primary point of contact for external study sites and leads all elements of site management, to include but not limited to site training and activation, site performance metrics (e.g. enrollment and data quality metrics) and study compliance. The CRA works under general supervision and is a valued and critical contributor to all phases of the study's lifecycle as the CRA's work directly influences overall study quality, metrics, schedule, milestones and budget.

Essential Duties and Responsibilities:

Serves as a clinical study site manager for assigned sites. Developing and maintaining successful working relationships with cross functional team members and site personnel; takes ownership of assigned sites by planning, conducting and reviewing tasks and accountabilities on an ongoing basis.

Supports execution of all phases of a clinical study from development to execution of final results, analysis and interpretation, as directed by the trial leader.

Leverages metrics on a routine basis to inform actions, evaluate trends, identify potential risks and plan proactive mitigations.

Contributes to the completion of study milestones, under the direction of the study leader.

May contribute 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.

Updates project plans and study timelines with support, as directed by the trial leader.

Supports accrual activity and site payments, reviews invoices and ensures payments are made according to active contracts for the assigned sites and/or vendors.

May assist with the management of deliverables from study consultants/contractors [contract research organizations (CROs), biostatisticians, independent core laboratories, clinical/medical experts, data analysts, etc.], as requested by the study lead.

Prepares, executes, and/or completes follow up activities for 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.

Supports the planning and conduct of investigator/study meetings.

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

Collaborates with numerous clinical roles (Clinical Information Systems, Safety, Monitoring, Clinical Quality, Payments, Core Lab, etc.) to produce deliverables and ensure high quality data and study conduct.

May provide oversight support of study committees (CEC, DMC, Publication, Steering) or work groups.

May support in the development and review of clinical trial reports and analyses, and/or regulatory reports and submissions (if applicable).

Issues proactive updates regarding the study status, progress and potential risks/mitigations to the study members, study lead and clinical leadership.

May support in forecasting of study devices, if required. Contributes to device accountability and reconciliation activities for the trial and assigned sites.

Supports trial leader with monitoring study compliance and any corrective action plans for assigned sites and across the study, as needed.

Supports maintenance and verification activities of site and project trial master files to enable audit readiness.

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

Bachelor' degree in biology, physical sciences, nursing or other related field

Minimum of two years of experience as a CRA supporting or leading projects through the clinical study lifecycle (Master' degree in a related field may apply to experience)

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 -Knowledge of clinical research guidelines and regulations governing conduct of global clinical trials

Demonstrated ability to work independently and generate solutions to a variety of problems with moderate complexity

Demonstrated history of results-driven orientation with ability to complete assigned tasks on time and with high quality

Demonstrated ability to communicate effectively and succinctly with internal and external personnel

Demonstrated ability to organize multiple work tasks and maintain attention to detail

Demonstrated ability to handle shifting priorities in a fast-paced environment while maintaining communication with team and manager

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

Specifications/Others:

* 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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