Clinical Research Coordinator I

$29 - $34/Yr

Thermo Fisher Scientific - Richfield, MN

Full-time

Richfield, MN

Computer and Electronic Product Manufacturing

About the position

Conducts at least one ongoing clinical trial that may involve patients or healthy volunteers. Interacts with the research site team and interdepartmental staff to ensure positive interactions with patients at site for study planning, from initiation to closeout. Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines. Provides medical care to patients, always ensuring patient safety comes first. 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 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.

Responsibilities

• Conduct ongoing clinical trials involving patients or healthy volunteers.
• Interact with the research site team and interdepartmental staff for study planning.
• Conduct clinical studies according to FDA/GCP and ICH regulations and guidelines.
• Provide medical care to patients, ensuring patient safety.
• Perform defined study activities including informed consent, screening, and protocol procedures.
• Record patient information and results from tests as per protocol.
• Complete IP accountability logs and associated information where required.
• Report suspected non-compliance to relevant site staff.
• Ensure IRB approval is obtained prior to study initiation and requirements are met throughout the study.
• Promote the company and build positive relationships with patients for retention.
• Attend site initiation meetings and relevant training meetings.
• Call patients for bookings and follow-up calls to confirm bookings or provide information/results.
• Log and complete information on sponsor systems accurately and within timeframe.
• Gather source documents and update patient files and notes.
• Adhere to company COP/SCOP.
• Dispose of waste according to standards and assist in maintaining facility appearance.

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability
• Retirement and savings programs, such as a competitive 401(k) U.S. retirement savings plan
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount