Clinical Research Manager

The International Spine, Pain & Performance Center is currently seeking an Experienced Clinical Research Manager! International Spine, Pain, and Performance Center is in search of a motivated professional interested in leading and participating in innovative medical research. The Clinical Research Manager (CRM), as delegated by the Chief Operating Officer, executes, and coordinates daily clinical research activities according to the company’s SOPs, GCP and FDA/ICH guidelines. Position Summary The CRM will serve as a senior clinical research professional and is responsible for the operational and financial management of the center’s clinical trials as well as the coordinator of complex research. This person will ensure IRB-approved protocols are implemented and followed; lead budget negotiations and annual research budget synthesis; execute the informed consent process and monitor patient status and safety; collect and organize research data; schedule and conduct study specific training and site in-services to educate staff on new or amended protocols; and educate patients and their families about treatments and possible side effects. Qualifications:· A Master’s degree AND 2-5 years of recent experience in clinical research OR an equivalent combination of education and experience is required;· In person position;· Must be proficient with Microsoft office applications (Outlook, Word and Excel) as well as internet based applications;· Must have excellent written and verbal communication, teamwork and problem-solving skills;· Must be professional, possess a high degree of self-motivation and have a strong work ethic;· Must be capable of recognizing, and have the willingness, to resolve errors and issues;· Must have the ability to adapt and take-on additional tasks as requested;· Must be detail oriented, organized, self-motivated and be able to work independently and on a team;· Must be capable of recognizing, and have the willingness, to resolve errors and issues;· Must possess a high degree of integrity and abide by HIPPA laws including maintaining patient confidentiality.CRM Key Responsibilities· Oversee all aspects of clinical trials that evaluate new medications and medical devices and ensure site quality· Ensure compliance with standards for safety and integrity, including data security, privacy, confidentiality and human subjects’ protection· Certify the research meets all relevant government regulations and standards· Directly supervise a team of clinical research assistants (CRAs) and clinical research coordinators (CRCs)· Oversee recruitment, onboarding, training and evaluation of staff· Develop and maintain an organization structure and the required staffing to accomplish goals and objectives· Act as liaison between the trial site and the clinical study sponsor to guarantee smooth study start-up and execution· Write study protocols and other research-related documents, as needed· Facilitate the creation and maintenance of IRB submissions and regulatory findings;· Supervise CRAs/CRCs with site preparation, obtaining informed consent, patient screening and recruitment, patient enrollment, conducting study visits, completion and quality control of case report forms, maintenance of source documents and responding to inquiries in a timely manner· Oversee the maintenance and dispensing of study product and supplies· Certify that project milestones/goals are met and while adhering to the clinical study budget· Design and maintain annual research budgets