Regulatory Associate

Summary This person will support clinical research trials and be primarily responsible for ensuring the timely and accurate submission of regulatory and IRB documents for new and ongoing studies. On average, the position will provide primary regulatory support for about 60 clinical trials. Ensures that the research site follows standard operating procedures, sponsor/CRO requirements, Food and Drug Administration (FDA) regulations, ICH guidelines, and good clinical practices about the conduct of clinical pharmaceutical and device protocols. Always maintains subject and document confidentiality, understands, and complies with the appropriate sponsor requirements, regulations including the Food and Drug Administration, good clinical practice (GCP), International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Boards (IRB), and institutional policies and procedures by performing the following duties. Duties and Responsibilities Works under limited supervision to assure compliance with federal regulations relating to human subject research. Understands and applies ethical principles and multiple regulations to complex scientific research projects. Review study protocols, informed consent documents, response to stipulations, and other study-related documentation, to assure conformance with all applicable requirements. Interacts with sponsors, IRBs, patients/subjects, and research staff members. Prepares, maintains, and provides oversight to all research-related regulatory documents. Populates and coordinates the entire process of initial regulatory documents"' submission to the IRB, sponsors, and state or federal regulatory offices as necessary. Compiles study information and submits initial, continuing, and final reports to the IRB and/or sponsor. Prepares applicable submission forms and submits updated documents, including but not limited to amendments, addendums, investigator's brochures, safety information, form FDA 1572s, and informed consent documents. Accurately files and maintains all necessary logs within the regulatory binder(s). Assists in and manages the archival of clinical trial documents/records. Prepares for monitoring visits and audits. Manages and updates employee curriculum vitas and ensures copies of all current and applicable medical licenses are on file. Abides by all HIPAA regulations. Maintains confidentiality of sponsor trade secrets. Creates error free written documents and reports such as cover letters, notes-to-file, and memos. Attend site initiation visits. Exercises judgement within the allowable limits defined within clinical trials protocols, standard operating procedures, and under the direction from the study Investigator and supervisor. Interacts with internal and external personnel, including but not limited to physicians, nurses, administration staff, industry sponsor representatives, central laboratory/imaging personnel, and clinical trial patients. Coordinates multiple projects with competing priorities and deadlines, as needed based on clinical trial protocol directives and study volume. Creates study source documents by accessing sponsor provided information and EDC/CRF. Maintains document control/version control on all released source documents. Perform other duties as assigned. Education / Experience High School Diploma or equivalent AND four to six years related experience and/or training; or equivalent combination of education and experience. Specialized Training CITI training certification GCP training certification IATA training certification Certificates and Licenses Valid driver's license Knowledge, Skills, and Other Abilities Demonstrate competence in oral and written communication Must be organized, attentive to detail, and possess a positive, friendly, and professional demeanor Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner Medical knowledge, including medical terminology Knowledge of CFR, GCP, and ICH guidelines required Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. Must have knowledge of Microsoft Office Word, Microsoft Excel, Internet Explorer, Google Chrome, Mozilla Firefox, web-based enterprise solutions, and Electronic Case Report Form systems. Work Environment and Physical Demands The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work is performed in an office/laboratory and/or a clinical environment. Occasional travel may be required, domestic and/or international. Ability to work in an upright and/or stationary position for 6-10 hours per day. Frequent mobility required. Occasional squatting, kneeling, or bending. Light to moderate lifting and carrying (or otherwise moving) objects with a maximum lift of 20-50 lbs. Perks of working at Summit Pinnacle Clinical Research 401k Medical, dental, vision, long-term disability, short-term disability, FSA, and life insurance 3 weeks of paid time off 14 paid company holidays Scrub voucher (specific positions apply) And more! Summit Pinnacle Clinical Research is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State/Province, or Local status unrelated to the performance of the work involved. #J-18808-Ljbffr Pinnacle Clinical Research- A Summit Solution