Clinical Research Specialist

INTEGRATED RESOURCES STAFFING PVT LTD 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. Thanks & Regards, Seema Chawhan Clinical Recruiter Integrated Resources, Inc. IT Life Sciences Allied Healthcare CRO Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I DIRECT # -  732 – 318 -6506  | (W) #  732-549-2030  – Ext – 324 | (F)  732-549-5549 Email id – seema @irionline.com| www.irionline.com  LinkedIn: https://in.linkedin.com/in/seemachawhan