Temple University - Philadelphia
,
PA
The OCR Regulatory Coordinator II is responsible for the accurate compilation and submission of protocols and related study documents to the FCCC Scientific Research Review Committee (RRC) and applicable Institutional Review Board (IRB), for maintaining OCR Regulatory Study Files to ensure all protocols and essential regulatory documents are complete and current in accordance with OCR and FCCC IRB Policy and Procedures, External Study Sponsor requirements, Good Clinical Practice Guidelines (GCP) and federal regulations and requirements set forth by the Food and Drug Administration (FDA), National Cancer Institute (NCI), and Office of Human Research Protection (OHRP) for the proper conduct of clinical trials at Fox Chase Cancer Center, Temple-Jeanes Bone Marrow Transplant (BMT) Unit and Temple University Cancer Center (TUCC). Education Bachelors Degree (Required) Masters Degree (Preferred) Combination of relevant education and experience may be considered in lieu of degree. Experience 2
- Today
Job Description: Reporting to the Director of Clinical Research, the Regulatory Analyst plays a pivotal role in ensuring compliance within clinical research projects. The primary responsibility involves completing and maintaining regulatory documents, aligning with study protocols, institutional policies, relevant regulations, and Good Clinical Practice (GCP) Guidelines. Responsibilities include overseeing day-to-day regulatory operations, managing study intake and feasibility assessments, facilitating start-up processes, handling Institutional Review Board (IRB) and Sponsor submissions, managing modification submissions, ensuring continuous reporting, and overseeing study close-out procedures. Additionally, the role encompasses providing financial support, liaising with internal and external stakeholders, and engaging with regulatory agencies as necessary. The Regulatory Analyst will maintain centralized documents, including credentials and training files for study staff, laboratory d
- Today
Temple University - Philadelphia
,
PA
The OCR Regulatory Coordinator II is responsible for the accurate compilation and submission of protocols and related study documents to the FCCC Scientific Research Review Committee (RRC) and applicable Institutional Review Board (IRB), for maintaining OCR Regulatory Study Files to ensure all protocols and essential regulatory documents are complete and current in accordance with OCR and FCCC IRB Policy and Procedures, External Study Sponsor requirements, Good Clinical Practice Guidelines (GCP) and federal regulations and requirements set forth by the Food and Drug Administration (FDA), National Cancer Institute (NCI), and Office of Human Research Protection (OHRP) for the proper conduct of clinical trials at Fox Chase Cancer Center, Temple-Jeanes Bone Marrow Transplant (BMT) Unit and Temple University Cancer Center (TUCC).EducationBachelors Degree (Required)Masters Degree (Preferred)Combination of relevant education and experience may be considered in lieu of degree.Experience2 Years
- 1 day ago
Northside Hospital Inc. - Atlanta
,
GA
Overview: Northside Hospital is award-winning, state-of-the-art, and continually growing. Constantly expanding the quality and reach of our care to our patients and communities creates even more opportunity for the best healthcare professionals in Atlanta and beyond. Discover all the possibilities of a career at Northside today. Responsibilities: Coordinates regulatory requirements integral to the conduct of clinical research. Ensures regulatory and organizational compliance in the compilation of complete, accurate, organized critical documents for physicians, study sponsors, Contract Research Organizations, and Institutional Review Boards. Routinely works with sensitive or confidential information, documents and issues. Qualifications: KNOWLEDGE SKILLS AND ABILITIES/LICENSE OR CERTIFICATION REQUIRED Bachelors Degree required, preferably in a healthcare / health sciences related field with 2 years experience in clinical research or IRB functions OR Masters Degree with 1 year experience
- 1 day ago
Acl Digital - Sewickley
,
PA
Regulatory Coordinator I 2000 Georgetown Dr, Sewickley, PA 15143 6 Months Contract Job Description Candidate will review internal and external products and raw materials to evaluate hazards and assign transportation classifications and maintain regulatory compliance in this entry-level scientific, non-laboratory position. We are looking for a team player who is self-motivated, able to maintain high quality while handling repetitive tasks, and manage multiple projects. RESPONSIBILITIES Work as part of team that provides support to all SW business units Apply GHS and Transportation regulations to assess product hazards Use outside vendor SDS to assess transport hazards Use in-house computer systems to assign transport classifications Assist with overflow regulatory compliance projects as requested QUALIFICATIONS Bachelors degree in Chemistry, Biochemistry, Biology, or related science Familiarity with regulatory programs - DOT/Transport preferred Working knowledge of Safety Data Sheets (S
- 2 days ago
Maverick Transportation, LLC - North Little Rock
,
AR
Description Regulatory Coordinator We have an immediate opening for a Regulatory Coordinator in our North Little Rock, AR office. If your background or education consists of maintaining compliance with DOT regulations, processing driver Personnel (HR) administrative records and excellent customer service skill, please apply. Responsibilities: Completes audit on each new driver file to verify DOT compliance has been met. Processes annual MVRs and Violation Review project for all employees. Reviews and responds to MVR monitoring alerts daily. Ensures all DOT physicals, CDLs, and driver licenses within the company remain valid. Processes DMV receipts for medical cards. Runs and monitors annual queries on the Drug & Alcohol Clearinghouse and oversees the random and preemployment drug screens. Clears PRE students through drug testing, physicals, compensated work, violations, and logbook prior to hire. Manages OSA needs for current drivers (sleep studies, cpap machines, compliance, machine m
- 2 days ago