Senior Clinical Research Coordinator
2 weeks ago
We are looking for a Senior Clinical Research Coordinator who will operate with minimal oversight, ensuring that all clinical studies uphold precise and current regulatory documentation.
This role will act as a pivotal resource for faculty engaged in clinical research. Ideal candidates will exhibit exceptional communication and organizational abilities, along with the capacity to work autonomously.
In collaboration with the Program Manager, Start-up Specialist, Research Nurse, and Program Coordinators, this position will support the initial Institutional Review Board (IRB) submission process.
Before the commencement of a study, the coordinator will verify that all necessary regulatory documents have received approval and that all essential documents, Case Report Forms (CRFs), databases, and monitoring/auditing requirements are fulfilled.
The coordinator will create and maintain a regulatory binder prior to the study initiation, compiling all required documents and additional sections for future submissions.
Working closely with Program Coordinators, the coordinator will ensure timely submission of all documents to the IRB.
Key ResponsibilitiesCollaborate with the Research Nurse, Principal Investigator (PI), and study coordinators on protocol amendments to guarantee prompt and accurate submissions to the IRB and sponsors.
Ensure that investigator-initiated protocol amendments contain complete and consistent language throughout, including proper reporting requirements for Serious Adverse Events (SAEs) and coordinating center stipulations.
Assist in the development of the Red Cap database for investigator-initiated studies prior to study activation.
Gather all required documents for protocol amendments for the IRB.
Submit and monitor each protocol amendment through the IRB/subcommittee approval process, identifying recurrent issues and implementing systems to minimize delays in the approval process.
Support the Start-up Specialist with new study IRB submissions as necessary.
Facilitate smooth study activation by collaborating closely with the Start-up Specialist, PI, Research Nurse, and Program Coordinators to collect all regulatory documentation.
For Investigational New Drug (IND) studies, maintain accurate and up-to-date documents and protocol amendment submissions.
Produce and sustain a regulatory binder prior to study initiation with all required documents.
Engage with all sponsors to ensure that all regulatory documents are reviewed, approved, and accurate before a study commences.
Ensure timely collection of all documents and that all regulatory binders are current. Meet with Program Coordinators and research assistants to review all documents before study activation.
Participate in regular meetings with the PI, Research Nurse, and study coordinator to discuss protocol amendments, deviations, and adverse event logs, as well as patient updates.
Assist Contract Research Organizations (CROs) in the auditing and monitoring of studies.
Support Program Coordinators and Assistants in the preparation and execution of monitoring visits.
Maintain a high level of expertise in institutional databases, including Epic, EPR, OnCore, and eIRB, utilizing this proficiency to ensure accurate data and analysis for all trials within the program.
Participate as requested in Cancer Center events, such as training and orientation for testing OnCore database updates and modules.
Attend monthly CRO Regulatory Specialist meetings.
Fulfill minimum requirements for continuing education units. Stay informed about and comply with Good Clinical Practice, ICH Guidelines, and institutional policies related to clinical research.
Ensure adherence to Cancer Center policies, Standard Operating Procedures, and guidelines concerning the conduct of clinical trials.
QualificationsMinimum Qualifications:
Bachelor's Degree in a related field.
Three years of relevant experience.
Additional education may substitute for experience.
Preferred Qualifications:
Master's Degree preferred.
Certification as a Clinical Research Professional is preferred.
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