Medical Director, Clinical Research Center - full time preferred but will consider part time
CTIAbout the role
What you'll do:
- Provides overall medical direction and medical review of protocols in accordance with the investigational plan and good clinical practice.
- Provides medical expertise and scientific feasibility for new sponsor inquiries.
- Ensures the safety and well-being of all participants in the study at the trial site.
- Ensures data collected at the study site is credible and accurate.
- Ensures the rights, integrity, and confidentiality of all participants in the trial at the site are protected.
- Collaborates with and provides guidance to clinical operations, research staff, and to sponsor client managers as required.
- Obtain and/or review participants’ medical history.
- Perform physical assessments, examinations and study procedures as required by study protocols.
- Evaluate and interpret clinical data and diagnostic information such as X-rays, ECGs, and lab work.
- Immediately report Serious Adverse Events —or any abnormalities affecting participants’ safety—to sponsors and to the IRB as required by study specific reporting guidelines.
- Oversee the administration of Investigational Product
- Review and adhere to study protocol.
- Be thoroughly familiar with the appropriate use of the investigational product (study drug) as described in the protocol and Investigator’s brochure/product monograph and other documents provided by the sponsor.
- Be aware and comply with ICH GCP (International Conference on Harmonization – Good Clinical Practice) and all applicable regulatory requirements.
- Training CRC staff through formal educational sessions as well as through daily interactions
- Other duties as assigned.
What you'll bring:
- Minimum qualifications include an M.D or D.O with an active medical license (medical license must be valid in the state in which the research is conducted).
- Training and certification in Good Clinical Practice (GCP)
- Direct patient care experience and demonstrated excellence in patient care.
- At least 3 years of clinical development experience and understanding of the principles of ICH-GCP, clinical trial design, and biomedical research ethics.
- Excellent communication, presentation, and people skills, including good command of English language (both written and spoken) is required.
- Confident and capable in the use of technology, applications, and other media
- Ability to establish and maintain effective working relationships with coworkers, managers, and study participants.
- Committed to the principles of collaboration, teamwork, civility, and respect.
- Effective mentoring and training skills, fostering learning and knowledge-sharing with colleagues.
Preferred:
- Principal Investigator at an academic site research organization
About CTI
CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com
Why CTI?
- Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
- Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
- Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.
Important Note
In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applyi
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