Clinical Research Regulatory Specialist I, Neurology

Position #: 240009UT
Position: Clinical Research Regulatory Specialist I, Neurology
UH Facility: Cleveland Medical Center
Shift: Days
Status: Full-time
Work Days of Week: M-F

City: Cleveland

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JOB DESCRIPTION & QUALIFICATIONS

Description

What You Will Do

Comprehends knowledge of scientific concepts related to the design and analysis of clinical trials; how drugs, devices and biologicals are developed and regulated.
Ensures care of the participants, aspects of human subject protections and safety in the conduct of a clinical research study.
Encompasses study management and GCP compliance; safety management (adverse event reporting) and handling of investigational product.
Facilitates all elements of communication within the site and between the site and sponsor, CRO and regulators; understands teamwork skills critical to responsible conduct of clinical research.
Embraces the principles and practice of leadership and professionalism in clinical research.

Additional Responsibilities

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.

Qualifications

Education

Bachelor’s Degree and some related experience (Required) or
Associate’s Degree with 4 years of clinical and/or research experience (Required)

Knowledge, Skills, & Abilities

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)
Write and edit technical documents. (Required proficiency)
Ability to understand and communicate regulatory requirements to others. (Required proficiency)
Medical terminology. (Required proficiency)
Excellent verbal, written, interpersonal skills. (Required proficiency)

Physical Demands

Standing Occasionally
Walking Occasionally
Sitting Constantly
Lifting Rarely 20 lbs
Carrying Rarely 20 lbs
Pushing Rarely 20 lbs
Pulling Rarely 20 lbs
Climbing Rarely 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

Travel Requirements

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LOCATION

Working at University Hospitals

Careers at University Hospitals offers opportunities to provide care locally in the Cleveland area with the power to impact healthcare nationwide. As a leader in our industry, our staff share a commitment to Be the Difference in the lives of our patients and our communities, from Northeast Ohio and beyond. Take a look at this video to discover how we’re building an organization for the future, today. Note: video content was obtained prior to the COVID-19 pandemic.

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Contact Us

To contact University Hospitals Human Resources department, or to request a reasonable accommodation, please call 216-767-8900 or send us an email at employment@uhhospitals.org

Equal Employment Opportunity Statement

It is the policy of University Hospitals to provide equal opportunity to all of our employees and applicants for employment. Decisions concerning employment, transfers and promotions or other conditions of employment are all made upon the basis of the best qualified candidate without regard to race, color, national origin, age, religion, veteran status, disability, gender, sexual orientation, gender identity, or marital status in accordance with Federal and Ohio law. A qualified individual with a disability will be considered for employment on the same basis as non- disabled applicants if he/she can perform the essential functions of the job sought, with or without a reasonable accommodation, and without imposing a direct threat to the health or safety of others or him/herself. EEO is the Law

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