What are the responsibilities and job description for the Part time Central Regulatory Coordinator position at INNOVO RESEARCH INC?
We are seeking a highly organized and effective Central Regulatory Coordinator II to join our team remotely. As the Central Regulatory Coordinator II, you will be responsible for managing and maintaining regulatory documentation (electronic regulatory binders), serving as a site liaison, and supporting compliance with regulatory requirements. This position reports directly to the Directors.
RESPONSIBILITIES
- Lead the centralized regulatory function across all Innovo clinical research sites.
- Develop 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 liaison to prepare for interim monitoring visits (IMVs), participate in SIVs, kick-off meetings, and conduct close out visits (COVs).
- Ensure each study is audit-ready (ex. IMV preparation, SIV/COV preparation, QA check on eReg, etc.) and support sites as directed in preparation for inspections and monitoring.
- Oversee and support the sites with study start-up collection, preparation, review, and submission of regulatory documents including 1572s, CVs, medical licenses, training logs, and financial disclosures
- Oversee the drafting, customization, and submission of ICFs across all studies and sites. Maintain version control and ensure sites are trained and using the most current IRB-approved versions.
- Responsible for regulatory documentation management; manage and maintain regulatory documentation including Institutional Review Board (IRB) submissions and amendments. Includes the timely 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.
- Track and maintain training documentation for the research team, as requested, to help ensure compliance with training requirements of Principal Investigators (PIs), Sub-Investigators (Sub-Is), and Clinical Research Coordinators (CRCs)/Research Assistants (RAs). Ensure CVs, medical licenses (MLs), Good Clinical Practice (GCP) training, International Air Transport Association (IATA) training, and Occupational Safety and Health Administration (OSHA) training are up to date.
- Performs all additional duties as assigned.
Qualifications:
QUALIFICATIONS
- Bachelor’s degree in life sciences, nursing, or related 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 Practice (GCP) standards.
- Strong organizational skills with the ability to manage multiple projects 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 mindset with a focus on accuracy and quality.
- Proficiency in Microsoft Office Suite and experience with clinical trial management systems (CTMS) preferred
Benefits
None.
WORKING CONDITIONS
This job operates in a remote environment with occasional site visits. This role routinely uses standard 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 beyond 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 found in SOP's, working guidelines, policies, etc. Innovo Research is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Innovo are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union 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. Innovo Research will not tolerate discrimination or harassment based on any of these characteristics. In addition, Innovo will provide reasonable accommodations for qualified 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 Visa at this time.
Salary : $25 - $26