Research Assistant - Regulatory (Clinical Research)

About Us: Each of reputed company’s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has reputed company experience and expertise in reputed company early phase trials, and reputed company our sites have in-patient capability. We focus on quality people, teamwork, and highly reputed company clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, reputed company Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Hourly reputed company: $20.00 - $21.50/hr (depending on education, experience, and skillset) Schedule: Monday - Friday 08:00 AM - 04:30 PM Job Summary: Assist the Regulatory Specialists/Manager in maintaining clinical trial documents for submission to regulatory agencies in accordance to site SOPs, ICH, GCP, and FDA guidelines. SOPs (Standard Operating Procedures) ICH (International Council for Harmonization) GCP (Good Clinical Practices) FDA (Food and Drug Administration) Essential Responsibilities and Duties: Complies with reputed company protocols, site SOPs, GCPs, IRB (Institutional Review Board) and FDA guidelines. Uploads regulatory documents with reputed company eDOCs System and files is reputed company binders, as necessary. Prepares, obtains, organizes and maintains regulatory and training documents in various storage mediums. Tracks submissions and ensure timely filing of documents. Obtains reputed company (Curriculum Vitae) of external Investigators and other contract personnel and their signatures for appropriate regulatory documents. Forwards revised copies of protocols, informed consents, and other pertinent study documents to appropriate staff. Assists in obtaining necessary signatures from investigators. Works closely with study sponsor/CRO and key clinical trial personnel on relevant regulatory document issues. Ensures Clinical Conductor regulatory information is reputed company. Participates in team meetings and complies with training requirements. Assists sponsors/CRO’s as needed. Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), reputed company standard operating procedures, site working Practices, protocol, and company guidelines and policies. Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as reputed company inclusive. Education/Experience/Skills: Must be able to effectively communicate verbally and in writing. Minimum: High School graduate or equivalent. Minimum of 1 year of reputed company experience in clinical research Must be self-directed and able to work with minimal supervision. Able to take a flexible approach to shifting priorities. Motivated to work consistently in a fast-paced and rapidly changing environment. Working Conditions Indoor, Office environment. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. Ability to work overtime, weekends, and/or holidays as needed. Ability to travel as needed. Remote work arrangement depending reputed company. reputed company Clinical Research is an Equal Opportunity Employer. reputed company applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national reputed company, veteran, or status. Apply To This Job