The role of the Clinical Research Monitor is to monitor investigator compliance with clinical research protocols according to applicable regulations and Good Clinical Practice (GCP), interfacing with Principle Investigators, study team members, and other research personnel in order to carry out this responsibility. Under general guidance and with latitude for exercise of independent judgment, ensures the integrity of the data collected by the Wilmot Cancer Institute Clinical Trials Office (WCI CTO).

Typical Duties:

For all clinical research protocols managed by the WCI CTO, including participating sites when applicable:

70%

Ensures IRB approved research studies managed by the Clinical Trials Office are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirements

- Conducts ongoing monitoring with a focus primarily on Investigator Initiated Trials sponsored by WCI

- Oversees all aspects of data monitoring, verifies data validity and integrity, and ensures the safety of participants in clinical trials by adhering to the institutional Data and Safety Monitoring Plan

- Conducts monitoring activities to reconcile clinical trial data, including Serious Adverse Events and other reportable events with adverse event, dose management, disease response, and other relevant study records

- Prioritizes monitoring activities commensurate with the degree of risk involved in study subject participation, as well as the size and complexity of the study

- 20%

- Prepares monitoring visit reports and follows up with study team to ensure outstanding issues are resolved

- 5%

Develops monitoring plan and tools prior to activation of Investigator Initiated Trials

- 5%

Provides input during the creation of study-specific electronic data capture systems for Investigator Initiated Trials sponsored by WCI

Job Type: Full-time

Pay: $58,800.00 - $82,300.00 per year

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Retirement plan
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift

Education:

• Bachelor's (Preferred)

Experience:

• Clinical research: 5 years (Required)
• Clinical trials: 5 years (Required)

Location:

• New York State (Required)

Work Location: Remote