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Clinical Research Specialist

Lancesoft Inc.
Saint Paul, Minnesota, 55112, United States
November 28, 2016


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.

Travel: N/A

Site: USA-MN-Mounds View

Shift Type: First

Position Responsibilities

• 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.

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.