Regulatory Coordinator - Clinical Research - Full-time

pstrongAbout Us: /strong/p pEach of CenExel’s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success./p pAlong with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k./p pstrongTHIS IS NOT A REMOTE POSITION/strong/p pstrongJob Summary: /strong/p pWith moderate oversight the Regulatory Coordinator I is responsible for the preparation, organization and implementation of regulatory research documents such as pre-study activities, initiation, execution, and reporting on the various status of research tasks in accordance with FDA guidelines, ICH GCP and SOPs. Maintain regulatory documents in accordance with applicable regulations and coordinate required investigator and study staff training./p pstrongSchedule: Monday - Friday 08:00 am - 4:30 pm /strong/p pstrongHourly Range: $29.00 - $35.00/hr (Depending on Experience) /strong/p pstrongEssential Responsibilities and Duties:/strong/p ul liCollects, prepares, and submits documentation to various sponsors/CROs during study start-up, including: Submission documents/approval, Protocol amendments with respective signature pages, Informed consent documents, FDA form 1572, Lab normal result documents, financial disclosure forms, Delegation of authority logs, Licenses, Reports. /li liLogs (e.g., temperature logs, drug accountability logs, master subject logs, screening and enrollment logs, specimen logs, etc.)/li liCollects, prepares, and submits documentation to institutional review boards for all ongoing and new trials./li liServe as a liaison between the IRB, site, and investigator./li liObtain necessary signatures from investigators and staff./li liMaintains and tracks current staff credentials (i.e., CV, certifications, etc.)/li liMaintains and distributes new and revised regulatory documents to applicable site staff and applicable corporate teams./li liRefers necessary regulatory questions to Sr. Regulatory Coordinator, Regulatory Manager or Regional Regulatory Manager./li liMaintains regulatory documents for ongoing trials, and ensures all appropriate regulatory documents are archived at the conclusion of the study./li liSubmits applicable subject facing documents for translations./li liMaintains current Clinical Conductor Regulatory information./li liPrepares appropriate reports for submission as required to the IRB including Serious Adverse Events (SAE’s), protocol deviations and other required reports./li liCompletes onboarding of new Investigators, including CV creation, obtaining medical license, and training documents./li liEnsures the regulatory binder is ready for monitor review during monitor visits. Meets with monitor, as necessary./li liAssists with regulatory inspections and sponsor audits as necessary./li liPerforms close-out duties including preparing the final report to the IRB and ensuring all original documents are filed in the regulatory binder. Ensures all appropriate regulatory documents are archived at the conclusion of the study./li liSupports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies./li liAssumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive./li /ul pstrongEducation/Experience/Skills:/strong/p ul liMust be a high school graduate or have GED equivalency./li lispan style="text-decoration: underline;"strong1+ years of regulatory experience in clinical research required/strong/span/li liDemonstrated prioritization and organizational skills to efficiently and effectively, providing accurate information in a timely manner./li liAbility to prioritize workload to meet demands of PI, coordinators, sponsors, and IRBs./li liAbility to prioritize workload to meet demands of PI, coordinators, sponsors, and IRBs./li liDemonstrated interpersonal skills to work with physicians, administrators, work colleagues, representatives from sponsors and others to achieve maximum efficiency in reaching and maintaining workplace goals in a professional manner./li liAbility to understand work may be delegated by more than one person, depending on the individual needs of the clinical study and to carry out job responsibilities as assigned in a timely manner./li liComputer skills using PC platform computers with proficiency in Excel and Word to enter data and generate correspondence accurately./li liAbility to learn and become proficient in eRegulatory systems, IRB portals, vendor portals and sponsor portals./li liA critical thinker with strong attention to detail and superb problem-solving abilities./li liMust be able to effectively communicate verbally and in writing./li /ul pstrongWorking Conditions /strong/p ol liIndoor, Office environment./li liEssential physical requirements include sitting, typing, standing, and walking./li liLightly active position, occasional lifting of up to 20 pounds./li liReporting to work, as scheduled, is essential./li liAbility to work overtime, weekends, and/or holidays as needed./li liAbility to travel as needed./li liRemote work arrangement depending on location./li /ol pCenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status./p p /p pstrongAbout Us: /strong/p pEach of CenExel’s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success./p pAlong with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k./p pstrongTHIS IS NOT A REMOTE POSITION/strong/p pstrongJob Summary: /strong/p pWith moderate oversight the Regulatory Coordinator I is responsible for the preparation, organization and implementation of regulatory research documents such as pre-study activities, initiation, execution, and reporting on the various status of research tasks in accordance with FDA guidelines, ICH GCP and SOPs. Maintain regulatory documents in accordance with applicable regulations and coordinate required investigator and study staff training./p pstrongSchedule: Monday - Friday 08:00 am - 4:30 pm /strong/p pstrongHourly Range: $29.00 - $35.00/hr (Depending on Experience) /strong/p pstrongEssential Responsibilities and Duties:/strong/p ul liCollects, prepares, and submits documentation to various sponsors/CROs during study start-up, including: Submission documents/approval, Protocol amendments with respective signature pages, Informed consent documents, FDA form 1572, Lab normal result documents, financial disclosure forms, Delegation of authority logs, Licenses, Reports. /li liLogs (e.g., temperature logs, drug accountability logs, master subject logs, screening and enrollment logs, specimen logs, etc.)/li liCollects, prepares, and submits documentation to institutional review boards for all ongoing and new trials./li liServe as a liaison between the IRB, site, and investigator./li liObtain necessary signatures from investigators and staff./li liMaintains and tracks current staff credentials (i.e., CV, certifications, etc.)/li liMaintains and distributes new and revised regulatory documents to applicable site staff and applicable corporate teams./li liRefers necessary regulatory questions to Sr. Regulatory Coordinator, Regulatory Manager or Regional Regulatory Manager./li liMaintains regulatory documents for ongoing trials, and ensures all appropriate regulatory documents are archived at the conclusion of the study./li liSubmits applicable subject facing documents for translations./li liMaintains current Clinical Conductor Regulatory information./li liPrepares appropriate reports for submission as required to the IRB including Serious Adverse Events (SAE’s), protocol deviations and other required reports./li liCompletes onboarding of new Investigators, including CV creation, obtaining medical license, and training documents./li liEnsures the regulatory binder is ready for monitor review during monitor visits. Meets with monitor, as necessary./li liAssists with regulatory inspections and sponsor audits as necessary./li liPerforms close-out duties including preparing the final report to the IRB and ensuring all original documents are filed in the regulatory binder. Ensures all appropriate regulatory documents are archived at the conclusion of the study./li liSupports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies./li liAssumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive./li /ul pstrongEducation/Experience/Skills:/strong/p ul liMust be a high school graduate or have GED equivalency./li lispan style="text-decoration: underline;"strong1+ years of regulatory experience in clinical research required/strong/span/li liDemonstrated prioritization and organizational skills to efficiently and effectively, providing accurate information in a timely manner./li liAbility to prioritize workload to meet demands of PI, coordinators, sponsors, and IRBs./li liAbility to prioritize workload to meet demands of PI, coordinators, sponsors, and IRBs./li liDemonstrated interpersonal skills to work with physicians, administrators, work colleagues, representatives from sponsors and others to achieve maximum efficiency in reaching and maintaining workplace goals in a professional manner./li liAbility to understand work may be delegated by more than one person, depending on the individual needs of the clinical study and to carry out job responsibilities as assigned in a timely manner./li liComputer skills using PC platform computers with proficiency in Excel and Word to enter data and generate correspondence accurately./li liAbility to learn and become proficient in eRegulatory systems, IRB portals, vendor portals and sponsor portals./li liA critical thinker with strong attention to detail and superb problem-solving abilities./li liMust be able to effectively communicate verbally and in writing./li /ul pstrongWorking Conditions /strong/p ol liIndoor, Office environment./li liEssential physical requirements include sitting, typing, standing, and walking./li liLightly active position, occasional lifting of up to 20 pounds./li liReporting to work, as scheduled, is essential./li liAbility to work overtime, weekends, and/or holidays as needed./li liAbility to travel as needed./li liRemote work arrangement depending on location./li /ol pCenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status./p p /p Apply tot his job Apply To this Job