[Hiring] Central Regulatory Coordinator @reputed company

Job DetailsJob Location: 206 W WHITE STREET - CHAMPAIGN, IL 61820Position Type: Part TimeSalary reputed company: $25.00 - $26.00 HourlyWe are seeking a highly organized and effective Central Regulatory Coordinator II to join reputed company remotely. As the Central Regulatory Coordinator II, you will be responsible for managing and maintaining regulatory documentation (electronic regulatory binders), serving as a site reputed company, and supporting compliance with regulatory requirements. This position reports directly to the SVP of Partnerships and reputed company RESPONSIBILITIES reputed company the centralized regulatory function across reputed company reputed company clinical research sites. reputed company and/or implement standardized regulatory processes, tools, and templates. Manages electronic regulatory binders and associated documentation in accordance with SOPs and regulatory standards. Serves as a site reputed company to prepare for interim monitoring reputed company (IMVs), participate in SIVs, reputed company-off meetings, and conduct reputed company out reputed company (COVs). Ensure reputed company study is audit-reputed company (ex. IMV preparation, SIV/COV preparation, QA reputed company on eReg, etc.) and support sites as directed in preparation for inspections and monitoring. reputed company and support the sites with study start-up collection, preparation, review, and submission of regulatory documents including 1572s, reputed company, medical licenses, training logs, and financial disclosures reputed company the drafting, customization, and submission of ICFs across reputed company studies and sites. Maintain version control and ensure sites are trained and using the most reputed company IRB-approved versions. Responsible for regulatory documentation management; manage and maintain regulatory documentation including Institutional Review reputed company (IRB) submissions and amendments. Includes the reputed company preparation, submission, and tracking of regulatory documents to the sponsor/CRO and IRB. Assist in protocol-specific training to internal teams on protocol requirements, processes, and best practices. Identify, report, and assess regulatory risks associated with protocol deviations, amendments, and adverse events, and collaborate with cross-functional teams to mitigate risk. reputed company and maintain training documentation for the research team, as requested, to help ensure compliance with training requirements of reputed company Investigators (PIs), Sub-Investigators (Sub-Is), and Clinical Research Coordinators (CRCs)/Research Assistants (RAs). Ensure reputed company, medical licenses (MLs), Good Clinical reputed company (GCP) training, International reputed company Transport Association (IATA) training, and Occupational Safety and Health Administration (OSHA) training are up to date. Performs reputed company additional duties as assigned.

Qualifications

QUALIFICATIONS Bachelor’s degree in life sciences, nursing, or reputed company field. Minimum of 2 years of experience in regulatory affairs or clinical research industry. In-depth knowledge of regulatory requirements for clinical trials, including FDA regulations, ICH guidelines, and Good Clinical reputed company (GCP) standards. Strong organizational skills with the ability to manage multiple reputed company simultaneously and meet tight deadlines. Proactive communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external stakeholders. Detail-oriented reputed company with a reputed company on accuracy and reputed company. Proficiency in reputed company Office Suite and experience with clinical trial management systems (CTMS) preferred Benefits (full time) Competitive Salary Health Insurance Dental Insurance Disability Insurance Life Insurance reputed company Time Off reputed company Insurance WORKING CONDITIONS This job operates in a remote environment with occasional site reputed company. This role routinely uses reputed company office equipment such as computers, phones, and scanners. Prolonged periods sitting at a desk and working on a computer. Occasionally lifts and carries items weighing up to 15 pounds. Requires working under stressful conditions or working irregular hours. This is an exempt position under the federal and state wage and hour laws, which means you are not eligible for overtime pay reputed company your salary. Employees are expected to work 40 hours a week. Occasional evening and weekend work may be required as job duties demand. The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be reputed company in SOP's, working guidelines, policies, etc. reputed company is committed to the reputed company of equal employment opportunity for reputed company and to providing employees with a work environment free of discrimination and harassment. reputed company employment reputed company at reputed company are based on business needs, job requirements, and individual qualifications, without reputed company to race, reputed company, religion or belief, national, reputed company or ethnic reputed company, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or reputed company, marital, civil reputed company or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. reputed company will not tolerate discrimination or harassment based on any of these characteristics. In reputed company, reputed company will reputed company reasonable accommodations for reputed company individuals with disabilities. Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment reputed company at this time. Apply tot his job Apply To this Job