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Company

City of Hope · 4 hours ago

MultiCtr Clin Research Monitor

United States

Full-time

Remote

Entry, Mid Level

2+ years exp

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AssociationEducation

Comp. & Benefits

No H1B

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Responsibilities

Perform review of eligibility case packets submitted to the COH Data Coordinating Center (DCC). Verify inclusion and exclusion criteria against source documentation to confirm patient eligibility for enrollment onto COH investigator initiated trials.

Manage registration tables for each assigned protocol to determine participant numbers, monitor Dose Level Toxicity assessments, track study accrual, and assign patients to different cohorts and dose levels.

Assist investigators in conducting site feasibility to ensure that site can appropriately accrue to the study prior to effort in site initiation as well as providing relevant information for budget development.

Collaborate with Clinical Trial Support Services (CTSS) to execute and track status of confidentiality agreements and sub site contracts/amendments.

Prepare and send study materials to external sites and request, review, and file regulatory documents prior to study activation.

Ensure that Site Initiation Visits (SIV) are coordinated in a timely fashion once contracts are executed.

Coordinate with the Clinical Research Coordinator for the assigned protocols and assist in the development of the site activation agenda, presentation, and training materials.

Schedule the SIV teleconference and ensure it is appropriately attended and maintain attendance documentation.

Assist clinical sites with account activation and provide eCRF training.

Liaise with the Clinical Trials Office (CTO), Office of Clinical Trials Auditing and Monitoring (OCTAM), Office of IND Development and Regulatory Affairs (OIDRA), Clinical Trial Support Services (CTSS), Clinical Trial Finance (CT Finance), Office of Clinical Protocol Development (OCPD), Data Safety and Monitoring Committee (DSMC) and Cancer Protocol Review and Monitoring Committee (CPRMC), Institutional Review Board (IRB), Principal Investigators (PIs), Biostatisticians, and serve as a primary point of contact for all study-related activities.

Serve as a subject matter expert to provide feedback on study-related documents, including (but not limited to), study protocol, informed consent template, study manuals, and Case Report Forms.

Maintain electronic systems for effective receipt, logging, tracking, and management of documents related to the management and monitoring of multicenter research. Such systems may include iRIS, eReg Binder, and OnCore as well as the case reporting form system.

Coordinate monthly conference calls with the COH study team and external sites to discuss study progress, enrollment issues, accrual status, etc., and issue meeting minutes in a timely manner.

Participate in team meetings with PIs to discuss study progress.

Assist in protocol development and protocol amendments.

Collaborate with Clinical Trials Finance (CT Finance) in reviewing monthly study accruals in the coordination of invoicing and budget management for participating sites.

Send updated study materials to sites as needed.

Perform other projects as assigned by the department Senior Manager, Multicenter Research Operations and/or Director, Safety and Data Quality.

Manage the Planned/Unplanned Deviation, Serious Adverse Event, and Unanticipated Problem reporting process (receive information/documents from sites, communicate with lead PI, prepare necessary FDA notification, and assist in the preparation of necessary site/sponsor notifications, etc.).

Support the regulatory and data collection aspects of the SIV for participating sites. Responsible for ensuring completion, collection, maintenance and management of all regulatory documents in eReg Binders.

Serve as a systems administrator in managing the central IRB for multicenter trials.

Perform periodic review of eReg Binders to ensure regulatory documents are current and coordinate with external sites to maintain current files.

Qualification

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Clinical ResearchMulticenter TrialsOncology TrialsHematology TrialsClinical Research CoordinatorRegulatory AffairsInvestigational New Drug ProceduresStudy ProtocolsInformed Consent ProcessClinical PracticesStandard Operating ProceduresDocument ReviewTraining DevelopmentProfessional Image

Required

Bachelor’s degree in biology, chemistry, biochemistry, physiology, nursing, or other related fields.

Two or more years of experience in Clinical Research

Preferred

Trained and certified as a Clinical Research Associate by the Association of Clinical Research Professionals (ACRP) or as a Clinical Research Professional by the Society of Clinical Research Associates (SoCRA).

Oncology and/or hematology clinical trials

Experience with multicenter clinical trials

Experience as a Clinical Research Coordinator/Associate

Experience as a regulatory affairs administrator

Familiar with Investigational New Drug procedures, study protocols, the informed consent process, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and applicable regulatory requirements

Exceptionally detail oriented

Excellent oral/written communication and organizational skills

Manage conflicting priorities and organize multiple tasks

Ability to efficiently review documents while focusing on specific data

Develop metrics, ancillary documentation, and training documents

Instruct/train others

Compose letters/memorandums/emails

Utilize resources to troubleshoot and solve problems

Foster and promote a positive image and professional appearance