What are the responsibilities and job description for the Clinical Research Regulatory Specialist II, Seidman Cancer Center (Hybrid) position at University Hospitals (SP)?
What You Will Do
- Coordinate and manage the regulatory operations for clinical research studies conducted by principal investigator(s) at University Hospitals Case Medical Center. (20%)
- Complete regulatory documentation required to conduct clinical research with the IRB, pharmaceutical sponsor, and other internal/external agencies or committees. (20%)
- 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. (30%)
- Manage regulatory processes to maintain compliance with SOPs, GCP guidelines, sponsor guidelines and current regulations. (20%)
- 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. (10%)
- Performs other duties as assigned.
- Complies with all policies and standards.
- For specific duties and responsibilities, refer to documentation provided by the department during orientation.
- Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.
Education
- 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) and
- ACRP Certified Professional (ACRP-CP) (Required)
- RAPS (Required)
- Standing Occasionally
- Walking Occasionally
- Sitting Constantly
- Lifting Rarely up to 20 lbs
- Carrying Rarely up to 20 lbs
- Pushing Rarely up to 20 lbs
- Pulling Rarely up to 20 lbs
- Climbing Rarely up to 20 lbs
- Balancing Rarely
- Stooping Rarely
- Kneeling Rarely
- Crouching Rarely
- Crawling Rarely
- Reaching Rarely
- Handling Occasionally
- Grasping Occasionally
- Feeling Rarely
- Talking Constantly
- Hearing Constantly
- Repetitive Motions Frequently
- Eye/Hand/Foot Coordination Frequently
- 10%