Clinical Trial Monitor
2 weeks ago
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 and Corrective 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
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