Clinical Research Specialist

Clinical Research Specialist

Job Title: Clinical Research Specialist

Location: Mounds View, MN Duration: 6 + months (Possibility of extension) Local candidate needed on site. Top 3 things CSH is looking for: 1. Clinical trial experience 2. Site Management experience 3. Medical Device experience DESCRIPTION:

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. Travel: N/A Site: USA-MN-Mounds View Shift Type: First

POSITION RESPONSIBILITIES Oversight of a clinical study including enrolment, 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.

BASIC QUALIFICATIONS 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. Presents professional manner and appearance

We do have referral bonus of $500 per candidate, if you refer any of your friends or colleague who are looking out for the same job.