Regulatory Submissions Manager
Are you an experienced CRA/ Site Manager/ IRB Associate looking for new opportunities in clinical research?
We are currently seeking key managers to join our Regulatory Submissions team in Clinical Operations.
The position is an office-based position in Cincinnati OH. The responsibilities include:
DESCRIPTION OF JOB DUTIES
- Efficiently manage and successfully execute all aspects of global start-up according to Sponsor specifications;
- Perform quality checks on submission documents and site essential documents;
- Interact with US central IRBs, sites, and international associates;
- Prepare and approve informed consent forms;
- Review pertinent regulations to develop proactive solutions to start-up issues and challenges; and
- Present during bid defenses, general capabilities meetings, and audits.
- More than 5 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience;
- Strong oral and written communication skills.
- Medpace offers an outstanding compensation and benefits package, including health, dental, PTO, 401(k) with match, and bonuses based on individual and company performance.
- We also offer a 24-hour on-site fitness facility with a personal trainer, as well as a business casual work environment.
To apply for this position:
Please send your cover letter and resume to: HR, Medpace, 5375 Medpace Way, Cincinnati, OH 45227; fax to: 513-579-0444; or e-mail to: [Click Here to Email Your Resume].
Medpace is committed to advancing the most streamlined and cost-effective path to drug approval and ultimately helping our sponsors improve people's lives. We approach drug development as a strategic partnership, leveraging our team’s significant expertise to deliver additional input, insight, and efficiencies to every phase of a trial. We are passionate about your success. We recognize that we share common goals and expectations regarding drug development with our partners. We view your triumphs as victories for our entire team.
Our unique partnering philosophy emphasizes our uncompromising commitment to research and to the highest level of ethical standards and performance in our jobs. We are selective about the number of projects we engage in because we are devoted to quality and providing our partners with best in class service. Medpace's dedicated teams serve as an extension of your team – we engage quickly and provide strategic thinking – ensuring quicker start-up times, superior quality, and the most efficient delivery of every phase of trial. Our therapeutic and regulatory experts are determined to streamline your path to approval so every partnership is designed to create research solutions focused on your critical needs.