Clinical Research Specialist
Careers Integrated Resources Inc
Clinical Research Specialist
INTEGRATED RESOURCES STAFFING PVT LTD
Job Description
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.
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