Clinical Research Associate (CRA) - Dallas

Job Summary 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. Backgrounds of individuals who have succeeded in the CRA role include

• Nursing
• Dietetics
• Nutrition Science
• Pharmacist
• Pharmaceutical/Device Sales Representative
• Physical and Occupational Therapists
• Biomedical/Chemical Engineer
• PhD/Post-Doc
• Pharm.D
• 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 Professionals Achieving CRA Excellence 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. PACE will prepare you by developing your CRA skills through interactive discussions and hands on job-related exercises and practicums. 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. WHY BECOME A CRA 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. The CRA position provides many other distinctive advantages including
• Dynamic working environment, with varying responsibilities day-to-day
• Expansive experience in multiple therapeutic areas
• Work within a team of therapeutic and regulatory experts
• Defined CRA promotion and growth ladder with potential for mentoring and management advancements
• Competitive pay and many additional perks unmatched by other CROs (SEE BELOW). WE OFFER THE FOLLOWING Competitive travel bonus; Equity/Stock Option Program; Training completion and retention bonus Annual merit increases; 401K matching; The 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, TSA pre-check; Opportunity for leadership positions - Lead CRA, CRA Manager, Clinical Trial 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 CRAs; and Opportunities 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 that 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; and
• Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Qualifications

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