119 regulatory coordinator jobs found

How You’ll Help Transform Healthcare: This position is responsible for reviewing proposed and final regulatory notices and coordinating with clinical and financial areas any changes needed related to these regulatory mandates. These mandates, if incorrectly implemented or not implemented at all, can result in substantial lost revenue and/or compliance issues for Carilion Clinic. Identifies trends and assists leadership in development of process improvement plans and provider education. Manages statistical tracking, the creation of spreadsheets and serves as a data resource for other departments. Stays informed of proposed and finalized regulatory changes. Works with clinical, financial and/or billing areas, to determine how the policy/coding changes affect Carilion Clinic from compliance, financial and/or operational perspectives. Assumes responsibility for conducting a financial and operational review of the proposed reimbursement changes and correct coding initiatives. Analyzes...

When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives. Job Type: Regular Scheduled Hours: 40 Work Shift: Day (United States of America) Job Summary: The Regulatory Coordinator performs basic regulatory administrative tasks and supports the regulatory team working on protocols and updates to the Dana Farber/Harvard Cancer Center (DF/HCC) IRB and audits. The Cancer Clinical Trials Office (CCTO) at Beth Israel Deaconess Medical Center (BIDMC) supports clinical research and provides infrastructure and services to 12 individual cancer disease programs: AIDS Oncology, Breast Oncology, Cutaneous Oncology, Experimental Therapeutics, Gastrointestinal Oncology, Genitourinary Oncology, Gynecological Oncology, Hematological Malignancies/Bone Marrow Transplant, Radiation Oncology, Renal Oncology, Thoracic Oncology, and Thrombosis/Benign Hematology. Job Description: Essential Responsibilities: Works with study teams to update essential...

Description Under the direction of the Operational Managers, Investigators, Financial Administrative Office, Faculty, Medical and Administrative Directors of the Jonsson Comprehensive Cancer Center (JCCC) Clinical Research Unit (CRU) the Regulatory Coordinator is responsible for preparation, submission and maintenance of regulatory applications to fulfill research requirements for open studies in addition to working with Sponsor monitors to timely process, review and collect regulatory documents maintained in the Investigator Site File. All work should be completed according to good clinical practice (GCP), JCCC CRU standard operating policies (SOP), UCLA Institutional Review Board (IRB) and government regulations. Work may be assigned by the direct supervisors, investigators or Senior Management. Assignments may be changed on an as-needed basis in order to ensure that study and patient care needs are handled appropriately and efficiently. Availability to work flexible hours...

Description Under the direction of the Operational Managers, Investigators, Financial Administrative Office, Faculty, Medical and Administrative Directors of the Jonsson Comprehensive Cancer Center (JCCC) Clinical Research Unit (CRU) the Regulatory Coordinator is responsible for preparation, submission and maintenance of regulatory applications to fulfill research requirements for open studies in addition to working with Sponsor monitors to timely process, review and collect regulatory documents maintained in the Investigator Site File. All work should be completed according to good clinical practice (GCP), JCCC CRU standard operating policies (SOP), UCLA Institutional Review Board (IRB) and government regulations. Work may be assigned by the direct supervisors, investigators or Senior Management. Assignments may be changed on an as-needed basis in order to ensure that study and patient care needs are handled appropriately and efficiently. Availability to work flexible hours...

Description The Data and Regulatory Coordinator is responsible for regulatory approvals and data entry support for studies which may include multicenter clinical trials (both NIH and industry-sponsored), local investigator-initiated clinical trials, and/or programmatic clinical research activities, such as a clinical database and biorepository. Essential to this role is a close collaboration with the Principal Investigator (PI) of each study, to facilitate timely study progress reporting to the PI and enabling appropriate PI oversight. You will be responsible for data management, including prompt and accurate case report form (CRF) data entry and query resolution, biospecimen tracking, including oversight for collection, processing and shipping. You will work with Principal Investigators, Sub-Investigators, support staff, federal and state agencies, industry partners, and other collaborative departments to coordinate and manage investigator-initiated and sponsor-initiated...

The Regulatory Coordinators (RC) works under the direction of the Principal Investigator(s), Clinical Research Manager and / or directly for the Clinical Trials Office to complete the regulatory requirements of the Thoracic clinical research project. The RC coordinates aspects of protocol submissions, prepares and submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal regulation and ICH/GCP guidelines. This position will work collaboratively with a variety of personnel at all levels, including faculty and study team members of DF/HCC and external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations. Works interactively with the Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the various DF/HCC institutions. This position is...

The Regulatory Coordinators (RC) works under the direction of the Principal Investigator(s), Clinical Research Manager and / or directly for the Clinical Trials Office to complete the regulatory requirements of the clinical research project. The RC coordinates aspects of protocol submissions, prepares and submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal regulation and ICH/GCP guidelines. This position will work collaboratively with a variety of personnel at all levels, including faculty and study team members of DF/HCC and external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations. Works interactively with the Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the various DF/HCC institutions. This position is remote...

The Regulatory Coordinators (RC) works under the direction of the Principal Investigator(s), Clinical Research Manager and / or directly for the Clinical Trials Office to complete the regulatory requirements of the clinical research project. The RC coordinates aspects of protocol submissions, prepares and submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal regulation and ICH/GCP guidelines. This position will work collaboratively with a variety of personnel at all levels, including faculty and study team members of DF/HCC and external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations. Works interactively with the Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the various DF/HCC institutions. Remote work my only be...

The Pediatric Solid Tumor Program at Dana-Farber Cancer Institute is seeking to hire a motivated Regulatory Coordinator (RC) to work within the Clinical Translational Research Program (CTIP) on trials specific to the Solid Tumor Clinical Trials portfolio. The pediatric Solid Tumor Program is one of the largest in the world and treats children with a range of solid tumor diagnoses providing novel and cutting edge therapies for these rare diseases. The Regulatory Coordinator (RC) will work under the direction of the clinical trial Principal Investigator(s), the CTIP Associate Director, and CTIP Clinical Research Manager to complete the regulatory requirements relevant to each clinical research project. The RC coordinates aspects of protocol submissions, prepares and submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal regulation and ICH/GCP guidelines. This position will work...

The Regulatory Coordinator (RC) works under the direction of the Principal Investigator(s) and Clinical Research Manager to complete the regulatory requirements of the clinical research project. The RC coordinates aspects of protocol submissions, prepares and submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal regulation and ICH/GCP guidelines. This position will work collaboratively with a variety of personnel at all levels, including faculty and study team members of DF/HCC and external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations. Works interactively with the Office for Human Research Studies (OHRS), Quality Assurance of Clinical Trials (QACT), and the Clinical Trials Offices at the various DF/HCC institutions. Regulatory Compliance: Prepares and submits all protocol...

Description Engage in research activities at UCLA Main Campus within the regulatory team situated in Westwood, operating under the guidance of Operational Managers, Investigators, the Financial Administrative Office (FAO), Faculty, Medical and Administrative Directors of the Jonsson Comprehensive Cancer Center (JCCC) Clinical Research Unit (CRU). The role involves the meticulous preparation, submission, and upkeep of regulatory applications essential for ongoing research initiatives. This entails collaborating with Sponsor monitors to ensure the timely processing, review, and collection of regulatory documents preserved within the Investigator Site File. Adherence to good clinical practice (GCP), JCCC CRU standard operating policies (SOP), UCLA Institutional Review Board (IRB) standards, and governmental regulations is imperative in all tasks. Task allocation may come from direct supervisors, investigators, or Senior Management, and these assignments could be subject to...

Description The David Geffen School of Medicine, Department of Urology is seeking to hire a full time Quantitative Study Coordinator. Under the direction of the unit Manager, you will function as a Study Coordinator in the Department of Surgery Research Core. You will work with the PI, Sub-Investigators, research personnel and hospital staff (collectively, the Study Team) to serve as Regulatory Coordinator for investigator-initiated and sponsor-initiated clinical trials and population based research projects funded by industry-sponsors, federal and state agencies, and other non-profit foundations and organizations. You will also be responsible for preparing, managing and submitting any required study/regulatory documents, and all required applications and forms, including but not limited to: submissions to the applicable Institutional Review Board (IRB), informed consent form development, required contractual and/or grant related documents, investigational pharmacy...

Reporting to an Associate Director within the Clinical and Translational Investigative Program (CTIP) and the specific disease center, the Regulatory Operations Manager (ROM) is responsible for supporting disease groups research portfolio; managing the development and quality control of protocol documents prior to IRIS and/or CHeRP submission, assisting with New Protocol Application (NPA) vetting and prioritization, ensuring that IRIS and CHeRP submission, review and approval timelines / institutional benchmarks are met. This position is the primary point person responsible for the collaboration / navigation with the Dana-Farber Cancer Institute (DFCI) and Boston Children’s Hospital (BCH) IRB contacts, clinical trial sponsors, the designated Principal Investigator and the disease group Clinical Research Manager to facilitate and streamline each process within established timelines. The ROM is responsible for closely managing regulatory submissions and communication following a...

The Senior Regulatory Operations Manager (Senior ROM) reports directly to the CTO Associate Director – Regulatory Operations, the CTO Sr. Director and assigned disease group research leadership. This position is responsible for overseeing the specific assigned disease group’s research portfolio and, when applicable, to share regulatory oversight within the assigned regulatory POD. Will be responsible for managing the development and quality control of protocol documents preparation prior to IRIS submission, assisting with New Protocol Application (NPA) vetting and prioritization, ensuring that IRIS submission, review and approval timelines / institutional benchmarks are met. This position is the primary point person responsible for the collaboration / navigation with the DFCI IRB contacts, clinical trial sponsors, DFCI designated Principal Investigator(s) and the disease group Clinical Research Manager(s) to facilitate and streamline each process within established timelines. The...

RN Registered Nurse / PRN / Employee Health Work location: Texas Health Arlington Memorial, 800 W. Randol Mill Road Arlington, TX 76012 Work hours: PRN / Various days of the week, 8 hours per day, PTO coverage for full-time staff At Texas Health Arlington Memorial , we take seriously our mission to improve the health of those in our community. We are a 369-bed, acute-care, full-service hospital serving our community since 1958. As part of the Texas Health family, we employ over 24,000 employees and are among the areas top five largest employers. Come be a part of our exceptional team as we continue to provide outstanding care and deliver award winning results. You belong here. Here’s What You Need Associates in Nursing, ADN is required. Bachelor’s Degree, Bachelor of Science in Nursing is preferred. (3) years RN experience as a clinical nurse is required. (3) years RN Med/Surg, Emergency Services or Occupational Health is preferred. Must hold an active RN license – Registered Nurse...

Registered Nurse (RN) Wound Care Fast-paced department is looking for top-skilled nurses. Is that you? Work location: Texas Health Dallas 8200 Walnut Hill Ln. TX 75231 Work hours: Full-Time | 40 Hours/week | Dayshift | Monday – Friday | 8AM- 5PM Department highlights: · Provides consultation and direct assistance to nursing staff for all WOC patients. · Assists staff to maintain current knowledge and competence for WOC patients through orientation, educational programs, role modeling, consultation and review of policies and procedures according to national guidelines. · Produces documentation that initiates, follows and revises patient’s plan of care. · Produces documentation that supports and meets regulatory requirements. Here’s What You Need · BSN preferred · Two year experience as a clinical nurse. · BCLS – Basic Cardiac Life Support and ACLS – Advanced Cardiac Life Support and CPI – Crisis Prevention Intervention Training 60 Days Req · RN must practice within the regulations...

Posting Details Posted : June 26, 2023 Full-Time Locations Showing 1 location 1320 W. Main St. 1320 W. Main St. Newark, OH 43055, USA 1320 W. Main St. 1320 W. Main St. Newark, OH 43055, USA +0 more less Job Details Description Compliance Coordinator Corporate Compliance Position Summary: The Compliance Coordinator is under the general direction of the Vice President of Financial Services.  The Compliance Coordinator is primarily responsible for review of patient accounts prior to billing to ensure appropriate CPT codes and modifiers are applied to services provided. Responsibilities: Review and analyze patient accounts that are pended due to system edits or payer denials. Maintain Corporate Compliance Audit Schedule. Keeps abreast of appropriate regulatory requirements related to coding and billing. Monthly completion of the Corporate Compliance dashboard. Active participation in committees and compliance meetings with individual departments throughout the organization. Identifies...

Posting Details Posted : September 25, 2023 Full-Time Locations Showing 1 location MFM DOWNTOWN CLINIC Downtown Clinic 700 S Main St. Moscow, ID 83843, USA MFM DOWNTOWN CLINIC Downtown Clinic 700 S Main St. Moscow, ID 83843, USA UI STUDENT HEALTH CLINIC Vandal Health Clinic | University of Idaho Campus 700 S Main St. Moscow, ID 83843, USA UI STUDENT HEALTH CLINIC Vandal Health Clinic | University of Idaho Campus 700 S Main St. Moscow, ID 83843, USA +1 more less Job Details Description Job Summary: The Clinical Lead will perform a variety of clinical tasks within their scope of training and certification, under the direct supervision of the healthcare provider working in the Gritman clinics and in compliance with the rules and regulations set forth by the Idaho Board of Medicine, Idaho Board of Nursing, Joint Commission, and Gritman Medical Center. The Clinical Lead must have excellent organizational and administrative skills. The Lead will perform a wide variety of leadership tasks...

Description Under the direction of the unit Manager, you will function as a Study Coordinator in the Urology Research Core in the Department of Urology. You will work with the PI, Sub-Investigators, research personnel and hospital staff (collectively, the Study Team) to complete the following duties: * Serve as Study Coordinator for research studies by assuring compliance with all aspects of individual studies. * Be responsible for ensuring that protocol procedures have been completed accurately, safely, and in a timely manner. * Be responsible for research assessment and study participant intervention under the supervision of the Principal Investigator (PI). * Be responsible for relevant regulatory and research practice guidelines must be adhered to in addition to ensuring the timely coordination and completion of study related procedures for which the coordinator is responsible. * Participate in patient recruitment and enrollment, data collection, source...

Description The Senior Clinical Research Coordinator is primarily responsible for coordination of the research activities in Clinical Research Unit within the Division of Hematology/Oncology under the direction of the investigators, Faculty Director of the JCCC CRU, Disease Site Investigator, and the senior management team (Director of Research, Medical Director, and Director of Finance and Administration). You will be is responsible for ensuring protocol procedures have been completed accurately, safely, and in a timely manner. This includes the responsibility for research assessment and patient intervention under the supervision of the Principal Investigator (PI).All relevant regulatory and Good Clinical Practice (GCP) guidelines must be adhered to in addition to ensuring the timely coordination and completion of study related procedures for which the coordinator is responsible. You will participate in patient recruitment and enrollment, data collection, source documentation,...