Description:The Regulatory Specialist is responsible for promoting compliance with Federal Regulations, Good Clinical Practice (GCP) and Institutional policies. The Regulatory Specialist will serve as liaison to investigators, collaborating divisions, departments and institutions, the Institutional Review Board (IRB) and external regulatory agencies.
Organizes and maintains the regulatory binder; file essential documents, obtain signatures for delegation logs, training logs and other essential study documents.
Reviews sponsor template and site level Informed Consent Forms (ICF) to assure compliance with GCP and International Conference on Harmonisation (ICH) guidelines.
Participates in the regulatory review, preparation, and submission of clinical study documentation (e.g. investigator brochure, Investigational Device Exemption (IDE), Investigational New Drug (IND), treatment and compassionate/emergent use, etc) as required.
Ensures timeliness and accurate submission of all protocol amendments, ICF, Investigator Brochure and other administrative items to the IRB of record.
Arranges for receipt and/or transmission of administrative and regulatory documents and files Serious Adverse Event (SAE) and IND safety reports.
Reviews and interprets IRB correspondence with the research team and notifies team of all determinations that may affect the safety and welfare of human subjects.
Acts as liaison between investigators, sponsors and their representative and the IRB on all regulatory issues.
Attends and actively participates in study team meetings, sponsor meetings and research meetings, and conferences/in-service education sessions as required.
Prepares the regulatory binder for monitor visits, audits or site inspections.
Additional Skills & Qualifications:2+ years of Regulatory experience in ideally sponsor initiated, investigator initiated and collaborative group studies (sponsor initiated 70% of workload is sponsor initiated; IITs are about 20% and Cooperative group 10%)1+ year of Oncology experience is required (more complex than other therapeutic areas but if someone has 6+ years of reg without oncology they might consider) 2 years of experience in regulatory | if not exactly regulatory at least some exposure to regulatory in clinical research (need experience with the IRB)IRB submissions experience - they work with 5 different types of IRBsBachelors is required (anything advanced would be better) Takes initiative and be present in person/owns the processExperience Level:Intermediate LevelAbout Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.