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Clinical Research Specialist

Integrated Resources, Inc

Mounds View, Minnesota

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JOB DETAILS
JOB TYPE
Contractor
SKILLS
Auditing, Cardiology, Clinical Practices/Protocols, Clinical Research, Clinical Trial, Communication Skills, Computer Skills, Contract Management, Cross-Functional, Csh (C Shell) Scripting, Detail Oriented, Establish Priorities, File Audits, File Maintenance, GCP (Good Clinical Practices), Interpersonal Skills, Maintain Compliance, Medical Equipment, Medical Terminology, Meeting Minutes, Microsoft Office, Multitasking, Organizational Skills, Presentation/Verbal Skills, Problem Solving Skills, Reconciliation, Regulatory Compliance, Regulatory Requirements, Research Contracts, Spreadsheets, Trend Analysis, Word Processing, Writing Skills
LOCATION
Mounds View, Minnesota
POSTED
Today
Clinical Research SpecialistINTEGRATED RESOURCES STAFFING PVT LTDJob DescriptionJob Title: Clinical Research SpecialistLocation: 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: FirstPosition ResponsibilitiesOversight 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 QualificationsBachelor'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.

About the Company

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Integrated Resources, Inc