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Position: Clinical Support Trials Coordinator

Dept: Oncology Clinical Trials

Shift: 8:00 AM-4:30 PM, 80 hours per pay

Facility: Miami Valley Hospital South

Position Summary

General Summary/Responsibilities:

The Clinical Trial Support Coordinator will function in a multi-faceted role and will be required to interact with investigators, study sponsors, clinical trial coordinators, contract research organizations, hospital/medical office personnel, etc. Effectively provide regulatory support services for assigned clinical research trials. Works to ensure compliance with Federal, State, Institutional and facility regulations and policies, as well as those specific to internal standard operating procedures and all applicable Institutional Review Board (IRB) policies. Develop study logs, tools and manuals for site use. Complete financial record keeping, including tracking payments, processing invoices, and reconciliation of research accounts. Support onsite CRAs, quality assurance, review and track monitor reports and metrics, and any other Clinical Trials operations tasks that may be assigned as appropriate. May review and provide input on protocols and assist in development of monitor plans. Other duties may include reviewing clinical trial data, including trending statistics, developing case report forms (CRF) for the collection of clinical trial data. Other areas the Clinical Trial Support Coordinator will be responsible for include, but are not limited to, data analytics, strategy, metrics, quality assurance, and any other Clinical Trials operations tasks that may be assigned as appropriate.

Data analytics - database support, with regards to research trials and patient information, build/update research calendar specification calendars and budgets, as well as ensure the integrity of data being collected and entered into the clinical trials management system (CTMS). In addition, the incumbent will assist in monitoring, verifying and validating the integrity of various data elements into the CTMS.

Metrics – assess key performance indicators (KPIs) that track the performance of a clinical trial against a standard or threshold. (i.e. version of ICF signed). Track growth metrics of program and each study. Track and provide assistance with maintenance of trial activities, enrollment, safety issues and records of active protocols at the different participating institutions.

Qualifications

Education

Minimum Level of Education Required: Bachelor's degree

Additional requirements:

Type of degree: Bachelor’s degree in relevant field

Area of study or major: Science, Healthcare, Business

Preferred educational qualifications: N/A

Position specific testing requirement: N/A

Licensure/Certification/Registration

Certification related to clinical trials/research preferred

Experience

Minimum Level of Experience Required: 1 - 3 years of job-related experience

Prior job title or occupational experience: minimum 1 year of relevant clinical trial experience preferred

Prior specific functional responsibilities: experience in the clinical research arena

Preferred experience: Project Management within Clinical Research

Other experience requirements: N/A