Clinical Research Associate II Job in Minneapolis, Minnesota US

Clinical Research Associate II


Description of Work:
The Clinical Research Associate II position assists in the planning, designing, and execution of high quality clinical studies to ensure safety and effectiveness of SJM products. Ensures compliance to applicable regulatory standards. Focus is on monitoring of investigational centers.

Essential Functions:
Assists with the management and development of study related documents including clinical protocols, case report forms, study manuals, and other study related tools.
Initiates site activation documentation
Participates in site qualification and site initiation process, including scheduling of monitor activities with site personnel.
Assists in planning and preparing materials for investigator and coordinator meetings.
Assists in training of investigators and coordinators.
Tracks and reports progress of studies, e.g. subject screening and enrollment, data collection, documentation of adverse events.
Coordinates and conducts monitoring visits at participating centers to ensure compliance to the clinical protocol, regulations, and timely receipt of data, including source document verification, device accountability, and writing of monitoring visit reports
Assists in query generation and resolution.
Assist with core lab data management.
Assists with the development and implementation of site corrective actions as needed to address any noncompliance issues.
Writes and/or provides input to the monitoring plan
Provides updates on progress of assigned clinical sites to study management.
Develops expertise with SOP's, GCP's, and regulatory compliance guidelines.
Participates in training/orientation or new employees.
Contributes to ongoing SOP review and development.
Reviews site changes to informed consent forms.
May create and conduct presentations.

Qualifications:
Four year degree or equivalent experience (four years in biological, physical, or engineering sciences) plus two years applicable health care experience.
1-2 years experience directly supporting clinical research or similar experience in a medical/scientific area.
High attention to detail and accuracy.
Strong written and oral communications skills.
Able to manage multiple tasks.
Knowledge of clinical and outcomes research study design
Knowledge of medical terminology.
Working knowledge GCPs, and regulatory compliance guidelines for clinical trials (e.g. applicable ISO Standards, FDA).
Good problem-solving skills.
Proficient computer skills (MS Office)
Able to travel 50% on average and up to 80% during peak periods may be required.

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St. Jude Medical is an Equal Opportunity Employer

St. Jude Medical is an equal opportunity employer. We value a diverse workforce across all spectrums, including opinion and experience. We seek out creative, conscientious, confident individuals who thrive on taking initiative. In return for those qualities, we offer outstanding compensation, comprehensive benefits and opportunities for professional growth.