Clinical Trial Monitor

Purpose/Scope:
The Clinical Trial Monitor will work under the Director of Industry Collaboration and Trial Management to oversee trial activity at sites participating in Alliance clinical trials. This position is responsible for completing clinical monitoring activities at participating sites for assigned trials. This includes Source Data Verification (SDV) of clinical study data entered on the Case Report Forms (CRF) in the Electronic Data Capture (EDC) system, review and reconciliation of the Investigational Site File (ISF) in line with NCTN mechanisms, confirm proper utilization and documentation of Investigational Product (IP), and ensure overall adherence to protocol procedures.
Role and Responsibilities
Conduct remote/on-site monitoring visits to ensure compliance with study protocols, clinical monitoring plan, Good Clinical Practice (GCP), institutional policy, and other applicable regulations.
Draft monitoring reports per trial’s established needs and expectations.
Perform source data verification (SDV) and review clinical documents for accuracy and completeness.
Cross-functional collaboration including with data management, quality, regulatory, and clinical operations.
Identify potential issues and risks and contribute to risk mitigation.
Conduct training for contracted monitors, with support of other team members.
Perform quality checks for contracted monitors.
Conduct co-monitoring visits as a sponsor representative.
Serve as a Subject Matter Expert for external monitors to consult with, with support of the internal team.
For assigned sites and/or trials, provide guidance to sites for inspection-readiness aspects including protocol requirements;
study procedures;
data integrity;
regulatory expectations;
training;
protocol deviations andCorrective and Preventive Action Plan implementation.
Support site adherence with GCP and other applicable regulations
Provide guidance on Investigator Site File and other relevant regulatory expectations, in line with NCI’s NCTN mechanisms.
Support data entry timeliness per Alliance policies
Assist sites in addressing and resolving data discrepancies and other queries.
Contribute to the development of the scope of work for monitoring services, and associated study plans, e.G., clinical monitoring plan.
Adhere to the protocols' Clinical Monitoring Plan, e.G., monitoring visit type, frequency, and required critical monitoring activities.
Coordinate upcoming and ongoing monitoring assignments while meeting expected timelines for the completion of monitoring activities including submission of monitoring reports.
Builds positive relationships with principal investigators and site personnel and actively participate with the study team to stay current with study needs.
Requirements
Qualifications and Education Requirements
Registered nurse or bachelor’s degree in a relevant life science field
Experience in therapeutic trials, oncology strongly preferred:
2 years experience in on-site monitoring as a Clinical Research Associate or 4 years experience as a Clinical Research Coordinator
In-depth knowledge of GCP, ICH guidelines, and other applicable regulatory requirements
Current certification of the Collaborative Institutional Training Initiative (CITI Program) GCP training or the ability to successfully complete training within 1 month of hire
Proficient in navigating Electronic Medical Record systems.
Proficient in using electronic data capture platforms and clinical trial management systems.
Ability to travel on a routine basis.
Preferred Skills
Excellent communication, interpersonal, and problem-solving skills
Ability to work independently and collaboratively in a fast-paced environment.
Strong organization skills with attention to detail
Fully COVID-19 Vaccinated
Benefits
100% Medical Option, Dental &
Vision for employee, with 50% spouse and children - begins on the 1st day of employment
20 Days PTO, 10 Sick Days &
10 Holidays Off (Already Designated)
Tuition Reimbursement
Match 3% of a Simple IRA.
50% Transit or Parking paid
Annual Employee Bonus Program
Annual Cost of Living Increase