Clinical Research Regulatory Specialist II, Seidman Cancer Center (Hybrid)

University Hospitals • Cleveland, OH

6d • Hybrid

About The Position

This role is responsible for coordinating and managing the regulatory operations for clinical research studies conducted by principal investigator(s) at University Hospitals Case Medical Center. The specialist will complete regulatory documentation required for clinical research with the IRB, pharmaceutical sponsor, and other internal/external agencies or committees. They will coordinate and perform study-specific regulatory processes across multiple complex studies of different therapeutic areas and phases, including IND or IDE held investigator-initiated trials. The role also involves managing regulatory processes to maintain compliance with SOPs, GCP guidelines, sponsor guidelines, and current regulations. Additionally, the specialist will embrace leadership and professionalism principles in clinical research, and provide mentorship and training on the clinical trial and regulatory process to staff members. Other responsibilities include performing duties as assigned, complying with all policies and standards, and abiding by all requirements to safely and securely maintain Protected Health Information (PHI) for patients.

Requirements

• Bachelor's Degree and some related experience (Required) or Associate's Degree with 4 years of clinical and/or research experience (Required)
• 2+ years of clinical research experience. (Required)
• Ability to prioritize the work of multiple projects. (Required proficiency)
• Detail-oriented person with the ability to work independently on multiple tasks and manage time effectively. (Required proficiency)
• Ability to work consistently and effectively as part of a high performance work team. (Required proficiency)
• Ability to understand and communicate regulatory requirements to others. (Required proficiency)
• Demonstrate problem solving skills and effective negotiation skills. (Required proficiency)
• Medical terminology. (Required proficiency)
• Strong written communication skills to write and edit documents with the ability to take scientific documentation and present to the general population. (Required proficiency)
• Excellent interpersonal and verbal communication skills. (Required proficiency)
• Basic knowledge of computer operations and demonstrated computer skills in a variety of software environments (ie Excel, Access, Word, database applications). (Required proficiency)
• Society of Clinical Research Associates (SoCRA) (Required)
• ACRP Certified Professional (ACRP-CP) (Required)
• RAPS (Required)

Responsibilities

• Coordinate and manage the regulatory operations for clinical research studies conducted by principal investigator(s) at University Hospitals Case Medical Center.
• Complete regulatory documentation required to conduct clinical research with the IRB, pharmaceutical sponsor, and other internal/external agencies or committees.
• Coordinate and perform study specific regulatory processes across multiple complex studies of different therapeutic areas and phases including IND or IDE held investigator initiated trials.
• Manage regulatory processes to maintain compliance with SOPs, GCP guidelines, sponsor guidelines and current regulations.
• Embraces the principles and practice of leadership and professionalism in clinical research.
• Provides mentorship and training on the clinical trial and regulatory process to staff members.
• Performs other duties as assigned.
• Complies with all policies and standards.
• Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree