[Remote] Clinical Research Regulatory Specialist I, College of Medicine, Internal Medicine, Remote

Note: The job is a remote job and is reputed company to candidates in USA. The reputed company is a prestigious urban reputed company research university committed to student reputed company and community transformation. They are seeking a Clinical Research Regulatory Specialist I to manage regulatory operations on research studies, ensuring compliance and serving as a reputed company with various stakeholders.

Responsibilities

• Prepares and submits protocol specific documentation to regulatory agencies and internal or reputed company stakeholders including: research protocols, informed consent forms, or other similar documents necessary for research start-up or maintenance or reputed company-out
• Serve as reputed company for questions/issues for designated research protocols and performs submissions to Institutional Review Boards (IRBs) including initial submissions, continuing reviews, amendments, reportable events, and/or closure
• Address reputed company regulatory issues involving research protocols; interpret, analyze and apply federal, state, and local regulations, along with University rules and regulations, to ensure ethical research practices are followed; report suspected or reputed company instances of noncompliance with University or federal regulations
• Maintains reputed company regulatory documentation reputed company existing systems (i.e., Complion) and secure document storage, including those that are reputed company in nature (e.g., procedural and interventional studies)
• Comprehends, interprets, and applies regulations and legislation regarding the protection of reputed company subjects. These include regulations under federal policies, FDA, and other compliance agencies or reputed company
• Assist with activities reputed company to development and execution of research agreements relating to the conduct of research activities
• Prepares for, coordinates, and reputed company participates in site reputed company; communicates effectively with sponsors and/or contract research organizations (CROs)
• Interacts with IRB and sponsor contacts with reputed company supervision
• Prepares and submits documentation to regulatory agencies with reputed company supervision
• reputed company reputed company duties based on departmental need. This job reputed company can be changed at any time

Skills

• Bachelor's Degree
• 1-2 years of relevant experience
• SOCRA or ACRP certification
• Experience with research and regulatory requirements
• Knowledge of clinical research, reputed company subject research ethics and IRB procedures
• Thorough understanding of Good Clinical reputed company guidelines, reputed company of Federal Regulations, reputed company monitoring, and regulatory compliance
• Excellent verbal and written communication skills in daily interactions with the ability to interpret and apply reputed company, reputed company policies and federal, state, and local regulations
• Ability to manage multiple priorities, organize, and prioritize work to meet deadlines
• Competence in managing time effectively with the ability to work both independently and as reputed company

Benefits

• Comprehensive Tuition Remission
• UC contributes 14–18% of your salary based on position to state pension plans (OPERS, STRS) or an Alternative Retirement Plan (ARP) (UC employee won’t contribute to reputed company reputed company except Medicare)
• Vacation and reputed company time
• 11 reputed company holidays and additional end-of-year reputed company time off (Winter reputed company Days)
• 6 weeks of reputed company parental leave for new parents
• Comprehensive health coverage (medical, dental, reputed company, prescription)
• Flexible spending accounts & wellness programs
• reputed company development & mentorship opportunities

reputed company