Regulatory Specialist - Hackensack, NJ
3 weeks ago
Job summary
The Regulatory Specialist is responsible for ensuring compliance with Federal, State, and Local Regulations,Good Clinical Practice (GCP), and Institutional policies and procedures.
A day in the life of a Regulatory Specialist at Hackensack Meridian Health includes: organizing and maintaining in audit ready condition at all times the regulatory binder (paper or electronic); reviews sponsor template and site level Informed Consent Forms (ICF) to assure compliance with GCP
and International Conference on Harmonization (ICH) guidelines; provides access to the most updated approved protocol
and related documents to the team via an established electronic process; tracks/updates all changes to informed consents
and send to sponsor for pre review prior to IRB submission; creates short forms for any translated language requested by
the clinical team; requests updated translations for all patient facing documents as needed for the clinical team;
participates in regulatory review preparation submission of clinical study documentation investigator brochure Investigational Device Exemption IDE Investigational New Drug IND treatment compassionate/emergent use etc as required ensures timeliness accurate submission of all protocol continuing reviews protocol amendments ICFs Investigator Brochures other administrative items IRB record notifies finance contract teams of amendments require updates Medicare Coverage Analysis budget contract initiate review tandem IRB update Oncore task lists regarding amendments under review assigns appropriate contract budget specialist ensure accurate updating maintenance regulatory documents pertaining DSMB Biosafety Committee Protocol Review Committee arranges receipt transmission administrative regulatory documents files Serious Adverse Event SAE IND safety reports Reviews interprets IRB correspondence research team notifies determinations may affect safety welfare human subjects obtains maintains lab/test ranges updates electronic databases personnel changes study status changes timely manner serves liaison investigators sponsors representative locations facilitates resolution questions through effective communication internal external entities stays abreast developments field clinical research assigned areas reading literature attending classes professional meetings etc assists developing procedures ensure regulatory compliance adheres HMH organizational competencies standards behavior
Job description
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