Clinical Research Specialist II, Pulmonary/Critical Care and Sleep Medicine

Position #: 240005CK
Position: Clinical Research Specialist II, Pulmonary/Critical Care and Sleep Medicine
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

A Brief Overview

Works with the Principal Investigator to coordinate all aspects of implementation of assigned multiple and/or complex clinical research trials.

What You Will Do

Responsible for submission of related documents to the appropriate regulatory review committees and maintenance of regulatory files. (10%; Competency 1, 2)
Performs all activities related to clinical research studies including but not limited to: screening participants for eligibility and recruitment, obtains informed consent, educates participants regarding study requirements and completes case report forms (CRF). (20%; Competency 1, 2)
Responsible for in-depth knowledge of protocol requirements and Good Clinical Practice (GCP) guidelines. (10%; Competency 1, 2)
Documents, records and assimilates accurate participant records and study records to ensure documentation compliance with sponsor guidelines, standard operating procedures (SOP) and internal and external regulatory agencies. (20%; Competency 1, 2)
Assists with SOP, grant and protocol development and active participant in preparation of manuscripts and presentations for scientific meetings. (10%; Competency 2,3)
Establish and maintain communications with Investigator, Sponsor and internal constituents. (10%; Competency 1, 2)
Mentorship of the clinical research process to the junior clinical research staff. (10%; Competency 3)
Performs other related duties as assigned or required. (10%; Competency 1, 2, 3)

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 (Required)

Work Experience

2+ years clinical research experience (Required) and
Experience in a team setting (Required)

Knowledge, Skills, & Abilities

Ability to prioritize the work of multiple projects. (Required proficiency)
Knowledge of GCP and FDA guidelines. (Required proficiency)
Knowledge of Electronic Data Capture Programs. (Required proficiency)
Medical & Research Terminology. (Required proficiency)
DOT/IATA Training (Preferred proficiency)
Ability to train and mentor junior staff. (Required proficiency)
Detail-oriented person with the ability to collect, compile, and analyze information. (Required proficiency)
Ability to understand and communicate research protocol requirements to others. Able to work independently on multiple tasks and manage time effectively. (Required proficiency)
Demonstrates customer service excellence with internal and external customers (Required proficiency)
Excellent verbal, written, interpersonal and communication skills. (Required proficiency)
Computer skills (Outlook, Excel, PowerPoint, Word). (Required proficiency)

Licenses and Certifications

Certification in Human Subjects Protection (CITI) within 30 Days (Required)
Society of Clinical Research Associates (SoCRA) (Preferred) or
ACRP Certified Professional (ACRP-CP) (Preferred)

Physical Demands

Standing Frequently
Walking Frequently
Sitting Rarely
Lifting Frequently 50 lbs
Carrying Frequently 50 lbs
Pushing Frequently 50 lbs
Pulling Frequently 50 lbs
Climbing Occasionally 50 lbs
Balancing Occasionally
Stooping Frequently
Kneeling Frequently
Crouching Frequently
Crawling Occasionally
Reaching Frequently
Handling Frequently
Grasping Frequently
Feeling Constantly
Talking Constantly
Hearing Constantly
Repetitive Motions Constantly
Eye/Hand/Foot Coordination Constantly

Travel Requirements

10% Travel may be required

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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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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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