Ohio Staffing
Medical Director, Clinical Research Center -FT/PT
Ohio Staffing, Cincinnati, Ohio, United States, 45208
Cti Clinical Research Center (CRC) Medical Director
The CTI Clinical Research Center (CRC) Medical Director will provide medical and clinical development expertise and medical leadership at the CRC. The role focuses on the execution, planning, and management of clinical studies at the CRC. The CRC Medical Director will function as a site principal investigator and will be responsible for ensuring the proper conduct of clinical trials and the safety of patients. Candidates will have specialized training and experience in any of the following disciplines: allergy/immunology, cardiovascular disease, dermatology, endocrine, hematology/oncology, gastroenterology, infectious diseases, internal medicine, nephrology, neurology, ophthalmology, pulmonary disease. Candidates with training in other disciplines are also eligible. Candidates with training and experience as site principal investigators are encouraged to apply. What You'll Do: Provide overall medical direction and medical review of protocols in accordance with the investigational plan and good clinical practice. Provide medical expertise and scientific feasibility for new sponsor inquiries. Ensure the safety and well-being of all participants in the study at the trial site. Ensure data collected at the study site is credible and accurate. Ensure the rights, integrity, and confidentiality of all participants in the trial at the site are protected. Collaborate with and provide guidance to clinical operations, research staff, and to sponsor client managers. 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. Train 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. About CTI CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused
The CTI Clinical Research Center (CRC) Medical Director will provide medical and clinical development expertise and medical leadership at the CRC. The role focuses on the execution, planning, and management of clinical studies at the CRC. The CRC Medical Director will function as a site principal investigator and will be responsible for ensuring the proper conduct of clinical trials and the safety of patients. Candidates will have specialized training and experience in any of the following disciplines: allergy/immunology, cardiovascular disease, dermatology, endocrine, hematology/oncology, gastroenterology, infectious diseases, internal medicine, nephrology, neurology, ophthalmology, pulmonary disease. Candidates with training in other disciplines are also eligible. Candidates with training and experience as site principal investigators are encouraged to apply. What You'll Do: Provide overall medical direction and medical review of protocols in accordance with the investigational plan and good clinical practice. Provide medical expertise and scientific feasibility for new sponsor inquiries. Ensure the safety and well-being of all participants in the study at the trial site. Ensure data collected at the study site is credible and accurate. Ensure the rights, integrity, and confidentiality of all participants in the trial at the site are protected. Collaborate with and provide guidance to clinical operations, research staff, and to sponsor client managers. 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. Train 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. About CTI CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused