Multi-Center Clinical Research Monitor (Remote)

Join the forefront of groundbreaking research at the Beckman Research Institute of City of Hope , where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research.

The Multicenter Research Operations office is part of the Safety and Data Quality department within the Research Protections unit under the Research Operations enterprise that provides support in the timely study start up, administration, and management of City of Hope investigator initiated multicenter trials. The primary responsibility of the Multicenter Research Operations office is to manage a portfolio of City of Hope investigator-initiated trials to ensure standardized practices are compliant with all institutional and regulatory requirements. In addition to providing services to external sites, the Multicenter Research Operations office also provides central registration services for City of Hope patients.

As a successful candidate, you will fulfill the following:

Eligibility Determination for COH and Participating Sites:

• Review eligibility registration packets and confirm patient eligibility for enrollment.
• Manage registration tables, monitor toxicity assessments, track study accrual, and assign patients to different cohorts and dose levels.

External Site Activation Activities for Participating Sites:

• Conduct site feasibility assessments, study start-up, and aid in budget development.
• Facilitate execution of confidentiality agreements and sub-site contracts.
• Conduct site initiation visits and assist with database account activation.
• Request and review regulatory documents to issue site activation.

Study Maintenance for Participating Sites:

• Liaise with various clinical trial departments and stakeholders.
• Maintain electronic systems for management of documents related to monitoring multicenter research.
• Distribute updated study materials to sub-sites.
• Facilitate monthly conference calls.
• Assist in development of study documents.
• Assist in data reporting requirements.
• Review and process invoices from sub-sites.

Regulatory Responsibilities for Participating Sites:

• Manage deviation, adverse event, and unanticipated problem reporting.
• Systems administrator in managing the central IRB for multicenter trials.
• Review and maintain regulatory documents.

Your qualifications should include:

• Bachelor’s degree in biology, chemistry, biochemistry, physiology, nursing, or other related fields. 
• Two or more years of experience in Clinical Research.

Preferred qualifications:

• Experience in oncology and/or hematology clinical trials and multicenter Investigator Initiated Trials.
• Experience as a Clinical Research Coordinator, Project Manager, or regulatory affairs administrator.
• Familiar with Investigational New Drug procedures, study protocols, the informed consent process, Standard Operating Procedures, Good Clinical Practices, and applicable regulatory requirements.
• Trained and certified as a Clinical Research Associate by the Association of Clinical Research Professionals or as a Clinical Research Professional by the Society of Clinical Research Associates.

City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity and inclusion, please click here .

To learn more about our Comprehensive Benefits, please CLICK HERE .