Research Compliance Cover Letter

I would like to submit my application for the research compliance opening. Please accept this letter and the attached resume.

In my previous role, I was responsible for senior level support for all research issues concerning funding policies, BWH/MGB policies, federal, state, local policy issues, human resource policies and proposed regulations as they relate to research.

Please consider my experience and qualifications for this position:

• Understand all key issues and monitor all alerts from 50 States, federal, agencies and treasury
• Be ready to have legal questions and conversations with legal team with little to no review
• Knowledge of human/animal subjects and Stanford, federal and state policies and procedures
• Knowledge of research procedures and terminology, medical terminology, clinical trials, and research data management
• Knowledge of global regulatory standards, quality systems and emerging guidelines
• Working knowledge of federal regulations and international standards related to the conduct of research, human subjects research, clinical research billing, and grants
• Knowledge of electronic research management systems for IRB (Institutional Review Board) management, clinical research management, and/or grants management, especially IRBNet and Clinical Conductor
• Experienced in clinical research administration, coordination and Good Clinical Practice (GCP) standards

In response to your job posting for research compliance, I am including this letter and my resume for your review.

In my previous role, I was responsible for privacy guidance to University research staff regarding the utilization, transfer and maintenance of research subject personally identifiable information, as well as de-identified and aggregate data, in accordance with federal and international regulations including: HIPAA, HITECH, FERPA and GDPR.

My experience is an excellent fit for the list of requirements in this job:

• Broad understanding of the regulatory framework of drug and device approval as it pertains to conducting clinical trials/late phase research
• Experience with the application of GCP guidance, federal regulations on Protections of Human Subjects and the HIPAA Privacy Rule
• Excellent interpersonal and communication skills, with demonstrated experience working effectively with personnel, government, members of the research community, and management across units
• Strong expository writing skills and high command of grammar and spelling
• Capable of maintaining highly sensitive and confidential information
• Experience with maintaining highly confidential information
• Experience working with databases, such as FileMaker Pro or MS Access or similar database
• Experience with updating websites

I submit this application to express my sincere interest in the research compliance position.

Previously, I was responsible for senior level support for all research issues concerning funding policies, PHS/BWH policies, federal, state, local policy issues, human resource policies and proposed regulations as they relate to research.

Please consider my experience and qualifications for this position:

• Certified IRB Professional (CIP) or Certified IRB Coordinator (CIC)
• Demonstrated experience with research integrity and compliance programs, including a deep knowledge of federal regulations
• Demonstrated experience working both independently and as part of a team
• Strong interpersonal skills, with demonstrated experience working effectively with personnel
• Experience drafting and implementing internal policies and facilitating the implementation of external regulations
• Graduation from college with a major in business administration, biological science, statistics, educational administration
• Experience in dealing with federal/state regulations
• Knowledge of policy, practice, and organization of federal funding agencies

I submit this application to express my sincere interest in the research compliance position.

In my previous role, I was responsible for one-on-one and group training to research staff to ensure compliance with federal and state regulations and laws, GCP/CMS/FDA and other external regulatory agencies, and internal research policies and procedures.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Effective human resource management skills
• Engaging with senior leaders to drive decisions for JPMC Corporate Compliance
• Building effective partnerships with key stakeholders within and outside Compliance Analytics, including Technology teams that run Mantas, Bridger, and other platforms, Compliance and Operations management, Model Review
• Over time, develop expertise in JPMC products, services and clients, and become a subject matter expert in multiple Compliance-related domains
• Experience leading a team of 2+ individuals
• Partner directly with analysts to address any updates/changes that need to be made to research/marketing materials and ensure all are in our system and approved to meet daily deadlines
• Proficient in using computer software applications such as Microsoft Excel, Word, PowerPoint, and Adobe
• Experience in developing and maintaining quality systems for clinical research studies and/or conducting quality assessments of external entities

I submit this application to express my sincere interest in the research compliance position.

In the previous role, I was responsible for leadership and vision for MMCRI and MH’s research programs, by stewarding and growing a thriving research portfolio through sponsored research, scientific collaboration and dissemination;.

My experience is an excellent fit for the list of requirements in this job:

• Proficiency with Excel, PowerPoint and Word strongly preferred
• Knowledge of the clinical research process, federal regulations that govern the conduct of clinical trials, training and/or quality assurance experience preferred
• Proficiency (written and spoken) in Arabic
• Training or experience in the areas of law, business (especially startups), or finance
• Experience in COI compliance or working within a university research or academic medical center compliance office, or healthcare organization with significant university research contacts
• Knowledge of relevant Federal (Public Health Service/National Institutes of Health) and State (California Fair Political Practices Commission) regulations, and University policies
• Project management experience, especially in the area of software implementation
• Should have or be able to obtain the 24 or 40-hour OSHA hazardous waste operations and emergency response training