Clinical Trials Scientific Review And Monitoring Coordinator

Clinical Trials Scientific Review And Monitoring Coordinator

This role supports high-impact oncology clinical research by coordinating scientific review and ongoing monitoring of clinical trials to ensure regulatory compliance, data integrity, and protection of human subjects. The Clinical Trials Scientific Review and Monitoring Coordinator works as part of a respected cancer research program, serving as a key liaison between investigators, scientific review bodies, and oversight committees. The position involves detailed review of clinical trial protocols and data, oversight of compliance with applicable regulations and Good Clinical Practice (GCP), and participation in study audits and monitoring activities in a fast-paced, intellectually stimulating environment.

Responsibilities:

• Coordinate and support scientific review and monitoring activities for oncology clinical trials in accordance with institutional policies and applicable regulations.
• Conduct detailed reviews of clinical trial protocols, informed consent documents, and related study materials to ensure scientific rigor, regulatory compliance, and protection of human subjects.
• Participate in and support internal and external study audits, including on-site and remote audits, to assess adherence to Good Clinical Practice (GCP), institutional requirements, and sponsor expectations.
• Monitor clinical trial conduct and documentation, including data quality, chart reviews, and adherence to protocol requirements, and identify potential issues or deviations.
• Collaborate closely with investigators, study coordinators, data management teams, and other stakeholders to resolve compliance issues and improve study processes.
• Interface with Institutional Review Boards (IRBs) and scientific review committees, assisting with submissions, responses to queries, and ongoing reporting as needed.
• Support clinical data management activities, including review of data in electronic data capture (EDC) systems and other clinical data platforms to ensure accuracy and completeness.
• Apply strong analytical and critical thinking skills to evaluate complex clinical research information and provide clear, actionable feedback to study teams.
• Manage multiple projects simultaneously, prioritize tasks, and meet time-sensitive deadlines in a fast-paced environment with competing priorities.
• Maintain thorough and organized documentation of monitoring activities, findings, and follow-up actions in accordance with institutional and regulatory standards.
• Contribute to the development and refinement of operational procedures and best practices that support exceptional compliance and operational excellence in clinical research.
• Build and maintain positive working relationships at all levels of the institution, fostering a collaborative and supportive team environment.
• Demonstrate a strong customer service attitude when interacting with investigators, staff, and external partners, providing clear guidance and support.
• Use advanced computer software tools to manage data, track activities, prepare reports, and support the overall scientific review and monitoring process.

Essential Skills:

• Minimum of a BA/BS in a relevant discipline, with a focus on biological sciences required.
• 23 years of experience and knowledge directly related to clinical research.
• Detailed knowledge of applicable regulations related to clinical research, including human subjects protections and Good Clinical Practice (GCP).
• Experience with Institutional Review Board (IRB) processes and/or scientific review of clinical research.
• Hands-on experience in clinical research operations, including clinical trials, monitoring, and auditing.
• Experience working with oncology clinical research and oncology clinical trials.
• Proficiency in clinical data management, including use of electronic data capture (EDC) systems and clinical data platforms.
• Demonstrated project and time management skills, with the ability to manage multiple studies and deadlines concurrently.
• Ability to work independently with minimal supervision while contributing effectively to a team environment.
• Outstanding organizational skills with strong attention to detail and documentation.
• Excellent written and verbal communication skills, including the ability to present complex information clearly to diverse audiences.
• Advanced computer software skills, including proficiency with common office and data management applications.
• Strong analytical and critical thinking skills, with the ability to evaluate complex clinical and regulatory information.
• Proven ability to build and maintain positive working relationships at all levels of an institution.
• Ability to work effectively in a fast-paced environment with time-sensitive deadlines and competing priorities.
• Demonstrated commitment to a customer serviceoriented approach when supporting investigators and research staff.

Additional Skills & Qualifications:

• Experience with IRB and/or scientific review in an academic cancer center is a plus.
• Prior involvement in chart review, monitoring, and compliance activities within clinical research.
• Familiarity with auditing processes for clinical trials and research programs.
• Experience working with human subjects research in oncology or other complex therapeutic areas.
• Comfort working with large datasets, clinical data, and data management workflows.
• Ability to contribute to the development of operational models and best practices recognized for excellence in compliance and operations.
• Demonstrated ability to function as part of a collaborative, intellectually stimulating team.
• Clear orientation toward continuous improvement and quality in clinical research operations.

Work Environment:

The position operates within a highly respected cancer research environment that is recognized nationally and internationally as a model for operational excellence and compliance. The team serves as agents for a major national cancer research body and is regarded as a pinnacle department within the broader institution. The culture emphasizes deep work, intellectual rigor, collaboration, and a strong sense of contributing to the greater good through impactful clinical research. The role offers significant workplace flexibility, including the ability to work remotely from locations within Pennsylvania, New Jersey, or Delaware. Coordinators must travel to campus for study audits that cannot be conducted remotely, typically 12 times per month, and must attend monthly staff meetings, regulatory inspections, and special training sessions on site. Candidates should live close enough to the city to make commuting to campus in Philadelphia reasonable. The environment is fast-paced, with time-sensitive deadlines and competing priorities, and it supports flexible windows for start and stop times for permanent staff. Permanent employees benefit from a supportive and collaborative culture, generous vacation time, seven paid holidays, and a paid winter break that minimally spans five workdays and often spans seven workdays. Additional benefits include substantial retirement contributions, employer-paid life insurance, tuition assistance, and discounts on services such as mobile phone plans, mortgage interest, transit passes, and event tickets, along with assistance with child care and other quality-of-life programs. Dress expectations align with a professional research and academic setting, particularly during on-site audits, inspections, and meetings.

Job Type & Location:

This is a Contract to Hire position based out of Philadelphia, PA.

Pay and Benefits:

The pay range for this position is $30.00 - $35.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type:

This is a hybrid position in Philadelphia, PA.

Application Deadline:

This position is anticipated to close on Sep 29, 2026.