Clinical Research Associate; Biomedical Engineering

Position: Clinical Research Associate (Biomedical Engineering Candidates)
Job Summary Join our CRA Team in Cincinnati, Ohio!

We are hiring those with Biomedical Engineering backgrounds for the CRA role!

The Clinical Research Associate position offers an exciting career within clinical research! For those with biomedical engineering backgrounds wanting to explore the research field, travel the US, and be part of a team bringing pharmaceutical and medical devices to market - this is the right opportunity for you!

This position is office based in Cincinnati, Ohio.

Medpace CRA Training Program (PACE)
No prior research experience is needed, as Medpace provides comprehensive initial and ongoing training, unmatched by other CROs. The PACE  (Professionals Achieving CRA Excellence) Training Program includes the following:

A platform to effectively and confidently carry out CRA duties to ultimately become a high-functioning, independent, Medpace CRAInteractive discussions with hands-on exercises and practicums

Core departmental rotations to learn various aspects of the drug/device development and approval process

Why CRA?

Exciting travel opportunities Make a difference on a larger scale through the development of medical drugs and devices Dynamic working environment with varying day-to-day responsibilities

Exposure to multiple therapeutic areas

Defined CRA promotion and growth ladder We Offer the Following:
Competitive travel bonus

Equity/Stock option program

Training completion and retention bonus

Annual merit increases
401K matching

Opportunity to work from home Flexible work hours across days within a week Retain airline reward miles and hotel reward points

Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere

In-house travel agents, reimbursement for airline club membership, and TSA pre-check

Opportunity for leadership positions – Lead CRA, CRA Manager, Training and Development Manager, and many moreCRA training program - PACE Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts

In-house administrative support for all levels of CRAOpportunity to work with international team of CRAs Responsibilities Conduct  qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol

Communication with the medical site staff including coordinators, clinical research physicians, and their site staff

Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff

Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements

On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward

Verification the investigator is enrolling only eligible subjects

Regulatory document review

Medical device and/or investigational product/drug accountability and inventory

Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol

Assess the clinical research site’s patient recruitment and retention success and offering suggestions for improvement

Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and…