Clinical Research Monitoring (CRA)

The Clinical Research Associate position at Medpace offers the unique opportunity to have an exciting career in the research of drug and medical device development while making a difference in the lives of those around them. For those with a medical and/or health/life science background who want to explore the research field, travel the US , and be part of a team bringing pharmaceutical and medical devices to market - this could be the right opportunity for you!
Our successful Clinical Research Associates possess various backgrounds in medical and other science-related healthcare fields. Nursing
Dietetics
Nutrition Science
Pharmaceutical/Device Sales Representative
Biomedical/Chemical Engineer
PhD/Post-Doc
Health and Wellness Education Coordinators
Public Health
Clinical Research Coordinators
Research Assistants

MEDPACE CRA TRAINING PROGRAM (PACE®)

No research experience is needed as Medpace provides comprehensive initial and ongoing training, unmatched by other CROs. Through our PACE® Training Program, you will join other P rofessionals A chieving C RA E xcellence: PACE® provides the platform to effectively and confidently carry out your duties, enhance your current abilities and ultimately help you become a high-functioning independent Medpace CRA. To supplement your in-house and field-based training you may also participate in other clinical research departmental core rotations, learning other aspects of the drug/device development and approval process. This role takes you on a journey through travel and excitement which will allow you to make a difference on a large scale through the enhancement of pharmaceuticals and medical devices. Work within a team of therapeutic and regulatory experts Competitive travel bonus; Equity/Stock Option Program; Training completion and retention bonus The opportunity to work from home; Flexible work hours across days within a week; Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere; In-house travel agents, reimbursement for airline club, TSA pre-check; Opportunity for leadership positions - Lead CRA, CRA Manager, Clinical Trial Manager, Training and 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 CRAs; Opportunities to work with international team of CRAs. 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; 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.

Must have a minimum of a Bachelor's degree in a health or science related field; Advanced degrees or prior clinical research experience is a plus; In-House CRA position available for those with no or minimal clinical research experience with rapid advancement;
Ability to travel 60-70% to locations nationwide is required; some visits may be conducted remotely;
Must maintain a valid driver's license and the ability to drive to monitoring sites;
Proficient knowledge of Microsoft® Office;
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
The work we do today will improve the lives of people living with illness and disease in the future.
Flexible work environment
Employee health and wellness initiatives
Community involvement with nonprofit organizations
Structured career paths with opportunities for professional growth
Discounts on local sports games, fitness gyms and attractions
Modern, ecofriendly campus with an on-site fitness center
Free on-site parking
Outdoor seating and workspace

Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility