Clinical Project Monitor, Associate

$58,800 - $82,300/Yr

University of Rochester - Rochester, NY

Full-time

Hybrid - Rochester, NY

Educational Services

About the position

The Clinical Project Monitor, Associate position at the University of Rochester involves coordinating study activities for multiple site clinical trials, ensuring compliance with clinical trial protocols, and interfacing with various stakeholders. The role requires monitoring investigator compliance with regulations and Good Clinical Practice (GCP), conducting on-site and remote monitoring, and participating in the development of Quality and Risk Management Plans.

Responsibilities

• Coordinates study activities for multiple site clinical trials.
• Assists the Manager in training on federal regulations, policies, and industry practices related to sponsored studies.
• Involved in qualifying community-based physicians as Principal Investigators (PIs) and physicians' offices as investigational sites for clinical research.
• Conducts on-site and remote monitoring activities nationwide to ensure compliance with clinical trial protocols, FDA regulations, SOPs, ICH, and GCP guidelines.
• Verifies that trial data is consistent with patient clinical notes and other source documentation.
• Independently coordinates ongoing and upcoming monitoring assignments and meets expected timelines for completion of monitoring activities.
• Develops and completes monitoring visit and/or teleconference reports and initial and follow-up communications to sites.
• Participates in the development and implementation of Quality and Risk Management Plans (QRMP) and associated Risk Assessment Categorization (RACT).
• Performs risk-based and centralized data review according to Monitoring Plan and QRMP/RACT.
• Applies root cause analysis, critical thinking, and problem-solving skills to identify site process failures and propose corrective/preventive actions.
• Participates in off-site monitoring activities and reconciliation of clinical trial data via electronic data capture system.
• Coordinates study start-up process, including the identification and initiation of new sites and site staff training.
• Stays abreast with and communicates new regulatory information to the project team.
• Assists with central file development, collection, review, tracking, and storage of regulatory documents required in a clinical trial.
• Facilitates and participates in meetings at various stages of the study.

Requirements

• Bachelor's degree in health, social science, or biological science field and 3-5 years of experience in clinical research coordination, or equivalent combination of education and experience.
• Knowledge of ICH, GCP Guidelines, and local regulatory authority regulations regarding clinical trials.
• Competence in electronic data capture systems including eConsenting.
• Familiarity with risk-based modeling approach and associated software.
• Strong verbal and written communication skills, interpersonal skills, attention to detail, and organization required.

Nice-to-haves

• Experience in bio/pharma/CRO preferred.

Benefits

• Competitive salary range of $58,800.00 - $82,300.00 based on experience and qualifications.