Top 3 things CSH is looking for:
1. Clinical trial experience
2. Site Management experience
3. Medical Device experience
Coronary Structural Heart Clinical is looking for an enthusiastic, motivated candidate to be a contract Clinical Research Specialist in our dynamic environment. The incumbent has responsibility for meeting the milestones of a clinical study in compliance with applicable clinical and regulatory standards and in alignment with the Study Manager as well as business needs. Work is completed under general direction.
Site: USA-MN-Mounds View
Shift Type: First
• Oversight of a clinical study including enrollment, long-term follow-up, trial master file maintenance and study activation phases.
• Ensure site compliance in regulatory requirements in regards to tracking site activation documents and ongoing study files by performing study file audits.
• Track device accountability reconciliation.
• Evaluate protocol deviation data during the conduct of the study and for completion of clinical study deviation trending requirements.
• Prepare weekly study reports and record meeting minutes.
• Assist in planning, coordination and preparation of meeting materials for investigator meetings.
• Regularly communicates study status to management.
• Bachelor’s Degree in a scientific field of study.
• Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.
• Minimum 3 years’ experience directly supporting clinical research or relevant experience in medical/scientific area.
• Master’s degree will substitute for 1 year of experience. PhD or MD will substitute for 2 years of experience.
• Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology.
• Computer skills (MS Office products, word processing, spreadsheets, etc.).
• High attention to detail and accuracy.
• Ability to manage multiple tasks.
• Good prioritization and organizational skills.
• Excellent problem solving skills
• Positive outlook.
• Flexible and dependable.
• Works effectively on cross-functional teams.
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