Clinical Research Associate (Biomedical Engineering Candidates)

Medpace, Inc.•Irving, TX

11d•Hybrid

About The Position

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 Dallas, TX. 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 a platform to effectively and confidently carry out CRA duties to ultimately become a high-functioning, independent, Medpace CRA, interactive discussions with hands-on exercises and practicums, and core departmental rotations to learn various aspects of the drug/device development and approval process.

Requirements

Minimum of a Bachelor’s degree in a health or science related field; degree in Biomedical Engineering preffered
Ability to travel 60-70% to locations nationwide is required
A valid driver’s license and the ability to drive to monitoring sites
Minimum 1 year healthcare-related work experience preferred
Proficient knowledge of Microsoft Office
Strong communication and presentation skills
Detail-oriented and efficient in time management

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 recommended actions to secure compliance

Benefits

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 more
CRA 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 CRA
Opportunity to work with international team of CRAs
Competitive compensation programs that recognize and reward performance
Comprehensive health, wellness, retirement, and PTO benefits
Office based culture with occasional WFH that provides flexibility for eligible positions after training
Company-sponsored social events and intramural sports