University Hospitals
Clinical Research Nurse Specialist I, RN - Clinical Trials Unit
University Hospitals, Cleveland, Ohio, us, 44101
Job Description - Clinical Research Nurse Specialist I, RN - Clinical Trials Unit (25000CG3)
A Brief Overview Provide safe and efficient age-specific nursing care to patients/families using the nursing process in combination with clinical research protocol requirements. Works in collaboration with the Principal Investigator to coordinate and implement assigned clinical research studies in accordance with Good Clinical Practice (GCP) guidelines.
What You Will Do
Responsible for submission of related documents to the appropriate research review committees and maintenance of regulatory documentation.
Performs day-to-day activities related to clinical research studies including: recruit and screens participants, obtain informed consent, educate participants regarding study requirements, and complete source documents and case report forms (CRFs).
Conducts nursing assessments of research participants including appropriate reporting.
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.
Establish and maintain communications with Investigator, Sponsor and other internal constituents.
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.
Education
Other Accredited Program: Diploma in Nursing (Required) or
(ADN) Associate's Degree in Nursing (Required) or
(MSN) Master's Degree in Nursing (Required)
Work Experience
2+ years of clinical experience in patient care. (Required)
Experience in a team setting (Preferred)
Knowledge, Skills, & Abilities
Ability to prioritize the work of multiple projects. (Required proficiency)
Knowledge of GCP and FDA guidelines. (Preferred 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. (Required proficiency)
Able to work independently on multiple tasks and manage time effectively. (Required proficiency)
Medical terminology. Excellent verbal, written and communication skills. (Required proficiency)
Computer skills : Excel, Access and Word. (Required proficiency)
Licenses and Certifications
Registered Nurse (RN), Ohio and/or Multi State Compact License (Required Upon Hire) and
Certification in Human Subjects Protection (CITI) Protection, Good Clinical Practices, HIPAA, and CITI Training (Required within 30 Days) and
Basic Life Support (BLS) (Required within 30 Days) and
OH Driver's License (Valid) with car insurance coverage. (Required within 30 Days)
DOT/IATA Training (Required within 30 Days)
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%
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A Brief Overview Provide safe and efficient age-specific nursing care to patients/families using the nursing process in combination with clinical research protocol requirements. Works in collaboration with the Principal Investigator to coordinate and implement assigned clinical research studies in accordance with Good Clinical Practice (GCP) guidelines.
What You Will Do
Responsible for submission of related documents to the appropriate research review committees and maintenance of regulatory documentation.
Performs day-to-day activities related to clinical research studies including: recruit and screens participants, obtain informed consent, educate participants regarding study requirements, and complete source documents and case report forms (CRFs).
Conducts nursing assessments of research participants including appropriate reporting.
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.
Establish and maintain communications with Investigator, Sponsor and other internal constituents.
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.
Education
Other Accredited Program: Diploma in Nursing (Required) or
(ADN) Associate's Degree in Nursing (Required) or
(MSN) Master's Degree in Nursing (Required)
Work Experience
2+ years of clinical experience in patient care. (Required)
Experience in a team setting (Preferred)
Knowledge, Skills, & Abilities
Ability to prioritize the work of multiple projects. (Required proficiency)
Knowledge of GCP and FDA guidelines. (Preferred 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. (Required proficiency)
Able to work independently on multiple tasks and manage time effectively. (Required proficiency)
Medical terminology. Excellent verbal, written and communication skills. (Required proficiency)
Computer skills : Excel, Access and Word. (Required proficiency)
Licenses and Certifications
Registered Nurse (RN), Ohio and/or Multi State Compact License (Required Upon Hire) and
Certification in Human Subjects Protection (CITI) Protection, Good Clinical Practices, HIPAA, and CITI Training (Required within 30 Days) and
Basic Life Support (BLS) (Required within 30 Days) and
OH Driver's License (Valid) with car insurance coverage. (Required within 30 Days)
DOT/IATA Training (Required within 30 Days)
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%
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