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).
UNEXPECTED REWARDS
Mid-sized CRO where you are not just a number
Dynamic working environment, with varying responsibilities day-to day
Expansive experience in multiple therapeutic areas
Work within a team of therapeutic, medical and regulatory experts
Internally designed propriety Clinical Trial Management System – one stop shop for EDC, IWRS, regulatory portal, visits reports, and more
Defined CRA promotion and growth ladder with potential for mentoring and management advancements
Opportunity to work from home once job experience is gained
Competitive pay.
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;
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
Bac+5 in Pharmacy or a health or science related field;
Ability to travel 60-80% to locations nationwide is required;
Must maintain a valid driver’s license and the ability to drive to monitoring sites;
Minimum 1 year healthcare-related work experience preferred;
Fluent in French & English is a must;
Strong communication and presentation skills; and
Must be detail-oriented and efficient in time management.
Medpace Overview
Medpace is a full-service clinical contract research organization (CRO) providing phase l-lV 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 the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.
Why Medpace?
When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.
Purpose-Driven Work
Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence
Collaborative Culture
Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
Leadership throughout Medpace is both accessible and approachable
Continuous Growth & Development
Office based environment with on-site mentors
Defined career paths with clear advancement opportunities
Industry renowned onboarding and training programs designed to accelerate professional development
Ongoing training and continuous learning opportunities throughout your career
An environment that encourages employees to influence change, contribute ideas, and grow quickly
Other Employee Benefits
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
Please note benefits may vary based on country.
What to Expect Next
A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.
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;
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.
Bac+5 in Pharmacy or a health or science related field;
Ability to travel 60-80% to locations nationwide is required;
Must maintain a valid driver’s license and the ability to drive to monitoring sites;
Minimum 1 year healthcare-related work experience preferred;
Fluent in French & English is a must;
Strong communication and presentation skills; and
Must be detail-oriented and efficient in time management.
