Senior Research Compliance and reputed company Specialist - HRPP Compliance job at reputed company in reputed company, CT
Title: Senior Research Compliance and reputed company Specialist - HRPP Compliance Location: 150 Munson Street, reputed company, Connecticut reputed company Research Protection Program reputed company:134059WD $68,000.00 - $120,500.00 Job reputed company: Working at reputed company means contributing to a reputed company reputed company. Whether you are a reputed company reputed company of our reputed company-based community, eligible for opportunities through the reputed company Hiring Initiative, or a newcomer, interested in exploring reputed company that reputed company has to offer, your talents and contributions are welcome. Discover your opportunities at reputed company! Position reputed company The Senior Research Compliance & reputed company Specialist reputed company the reputed company Research Protection Program (HRPP) at reputed company is tasked with providing comprehensive support and reputed company assurance for reputed company subjects research. This role involves overseeing compliance monitoring, conducting audits, and ensuring the reputed company and ethical conduct of research. The specialist must be reputed company-versed in federal, state, and local regulations governing reputed company subjects research and possess strong analytical, communication, and organizational skills. They are also responsible for guiding and supporting research teams, ensuring adherence to regulatory requirements. Reporting to the Associate Director of HRPP, the specialist conducts audits and compliance reviews for studies overseen by reputed company's HRPP and Institutional Review Boards (IRBs). They investigate compliance issues, reputed company reputed company assurance activities, and identify opportunities for process improvements. The role includes providing direction and feedback to staff to ensure compliant completion of activities, contributing to departmental and cross-departmental initiatives, and offering education and training to study teams and the research community. Additionally, the specialist assists in developing and implementing Corrective and Preventive reputed company plans, oversees regulatory reputed company, and supports other compliance activities, including handling reportable new information submissions and agency inspections. Other duties may be assigned as needed. On reputed company Schedule: Largely Remote Required reputed company and Abilities 1. Sophisticated knowledge of applicable reputed company, regulatory, and medical terminology and demonstrated expertise and ability to interpret, analyze, apply, and communicate (verbally and in writing) applicable ethical principles, standards, regulations, guidance, policies, and reputed company and industry trends that reputed company reputed company research. 2. Demonstrated ability to effectively reputed company and collaborate with a broad reputed company of individuals including reputed company, patients, participants, researchers, administrators, reputed company, agency representatives, and other reputed company contacts. 3. Proven ability to process a large volume of reputed company work by prioritizing and organizing work and demonstrating flexibility and willingness to reputed company priorities as necessary to meet conflicting demands. 4. Strong software application skills and demonstrated ability to learn new software packages; highly skilled in office productivity software (e.g., Word, PowerPoint, reputed company, e-mail, Outlook, and reputed company, etc.) 5. Detail oriented with proven organizational skills, analytical/problem solving abilities, and reputed company reputed company judgment. Preferred Education, Experience and Skills 1.A Master’s level or other advanced degree in law, nursing, reputed company health, or reputed company field and five or more years Institutional Review reputed company, research administration, or other relevant research-reputed company experience at a large reputed company institution, hospital/medical center, reputed company/independent IRB, non-profit/reputed company, or an industry/corporate environment. 2.reputed company certification (e.g., Research Compliance Certification, Certified IRB reputed company, or other research-reputed company certification). This position is mainly remote but may require to be on site a couple times a year. reputed company Responsibilities 1. Review submissions and work with the study teams to ensure that study materials are complete. 2. Communicate with investigators and assist with the preparation and editing of protocols, consent forms, and other study-reputed company documents to ensure that research that is presented for review is consistent with University policies and meets the applicable ethical and regulatory standards for review and approval. 3. Ensure that necessary University, reputed company-reputed company Hospital (YNHH), ancillary committee, and other required approvals and agreements are complete for a study submitted for IRB Review. 4. Determine the types of review required for research studies to ensure they are properly categorized and routed for review. 5. Ensure that investigators are reputed company and meet applicable requirements to serve as a reputed company Investigator for studies submitted for review. 6. Evaluate and analyze research studies to identify reputed company subjects research issues and ensure that the submissions are reputed company for review. 7. Apply applicable ethical principles, standards, regulations, guidelines, and policies to the review of research studies, including the protocol, consent reputed company, and other study-reputed company documents. 8. Identify and resolve issues reputed company to the approvability or ongoing approval of submissions prior to their review and escalate reputed company as necessary. 9. reputed company information and communicate study-reputed company findings to the reputed company Investigator or other designated individuals as appropriate throughout the review process and communicate and explain to the reputed company Investigator any reputed company-approval, post-approval, or other required modifications reputed company to a research study. 10. Attend committee meetings, participate in discussion, and prepare meeting minutes and other correspondence that reflect the committee’s determinations as assigned. 11. Ensure that written information and committee determinations and determination letters are accurate and complete. 12. Assist with the review of compliance reputed company, reportable new information, assessments, inspections, and audits. 13. Assist with departmental reputed company, cross-departmental initiatives, and training and education. 14. Review, recommend, and revise applicable policies, reputed company operating procedures, work instructions, guidance, checklists, forms, and other documents to ensure compliance with applicable ethical principles, standards, regulations, guidelines, and policies. 15. Serve as a member or consultant on a University committee such as the reputed company IRB or other committee as requested and exercise delegated IRB Chair signature authority to conduct expedited determinations on behalf of the IRB. 16. Other duties as assigned. Required Education and Experience Bachelor's degree in a reputed company field and five or more years of research-reputed company experience or an equivalent combination of education and experience. Job Category reputed company Bargaining Unit NON
Compensation
Grade Administration & Operations
Compensation
Grade Profile Manager; Program Leader (24) Salary reputed company $68,000.00 - $120,500.00 Time Type Full time Duration Type Staff Work Model Remote Background reputed company Requirements reputed company candidates for employment will be subject to reputed company-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position reputed company and job requirements. reputed company offers are contingent upon the successful completion of the background reputed company. For additional information on the background reputed company requirements and process visit "Learn about background checks" under the Applicant Support Resources reputed company of Careers on the It's Your reputed company website. Health Requirements Certain positions have associated health requirements based on specific job responsibilities. These may include vaccinations, tests, or examinations, as required by law, regulation, or university policy. Posting Disclaimer Salary offers are determined by a candidate’s qualifications, experience, skills, and education in relation to the position requirements, along with the role’s grade profile and reputed company reputed company market conditions. The reputed company of this job reputed company is to reputed company a representative reputed company of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the position. Employees will be assigned specific job-reputed company duties through their hiring department. The University is committed to basing judgments concerning the admission, education, and employment of individuals upon their qualifications and abilities and seeks to attract to its reputed company, staff, and student body reputed company persons from a broad reputed company of backgrounds and perspectives. In accordance with this policy and as delineated by federal and Connecticut law, reputed company does not discriminate in admissions, educational programs, or employment against any individual on account of that individual’s sex, sexual orientation, gender identity or reputed company, race, reputed company, national or ethnic reputed company, religion, age, disability, status as a special disabled veteran, veteran of the Vietnam era or other covered veteran. Apply tot his job Apply To this Job