CRCII
at Thermo Fisher Scientific
Richfield, MN 55423, USA -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 22 Sep, 2024 | Not Specified | 22 Jun, 2024 | N/A | Processing,Interpersonal Skills,Safety Monitoring,Discretion,Communication Skills,Informed Consent | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
OPT | H4 Spouse of H1B |
GC Green Card |
Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
Description:
KNOWLEDGE, SKILLS & ABILITIES:
- Solid understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.)
- Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving
- Demonstrated ability to exercise discretion and sound judgement
- Good decision-making, negotiation and influencing skills
- Good communication skills and English fluency will be an advantage
- Good organizational skills
- Good proficiency in basic computer applications
- Good interpersonal skills to work in a team environment
Responsibilities:
- Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.
- Provides medical care to patients, always ensuring patient safety comes first.
- Schedules subject visits within protocol windows, ensuring scheduling capacity is maximized.
- Performs all defined study activities (i.e., informed consent, screening, and protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, ECG’s, etc.).
- Records all patient information and results from tests as per protocol on required forms.
- Where required, may complete IP accountability logs and associated information.
- Reports suspected non-compliance to relevant site staff.
- Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.
- Promotes the company and builds a positive relationship with patients to ensure retention.
- Attends site initiation meetings and all other relevant meetings to receive training on protocol.
- May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results.
- Logs/completes information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe.
- Gathers and maintains source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.
- Adheres to company COP/SCOP.
- May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility.
REQUIREMENT SUMMARY
Min:N/AMax:5.0 year(s)
Hospital/Health Care
Pharma / Biotech / Healthcare / Medical / R&D
Health Care
Graduate
Proficient
1
Richfield, MN 55423, USA