Clinical Research Coordinator RN-Gene Therapy

Overview : Schedule : Day Shift

This position works with adults and children that have neuromuscular diseases. Studies are generally multi-year studies which allows for building relationships with families that are participating in the trials.

Job Description Summary :

Works with the study physician to ensure all patients involved in a clinical research trial are managed uneventfully, safely, and as effectively as possible through their episode of care and participation in the clinical research trial, ensuring patient care is not compromised while participating in the trial. Manages all elements of a clinical research trial in order to meet all protocol obligations while following applicable regulations; Code of Federal Regulations Good Clinical Practices (GCP) and International Conference on Harmonization GCP guidelines; state regulations and departmental / institutional standard operating procedures.

Job Description :

Essential Functions :

• Plans, implements, educates and evaluates care plan using Evidence-Based Practices in accordance with the requirements of the study protocol
• Provides nursing care using a Family Centered approach throughout their clinical study participation while maintaining quality and safety as a priority. Delegates, directs, oversees and provides developmentally appropriate patient care. Practices professional nursing and promotes patient advocacy in accordance with the ANA Code of Ethics for Nurses and maintains a current Ohio Nursing License
• Collaborates effectively and communicates patient care needs / expectations / priorities related to clinical trial participation to all involved care providers including unit nursing staff, attending physician, ancillary service providers (radiology, cardiology, physical therapy, pharmacy, etc.) to facilitate positive patient outcomes both in clinical care and in clinical trial participation
• Completes and manages all procedural, data, regulatory and training elements associated with clinical research project implementation, execution and close out to ensure participant safety, data integrity and compliance with all applicable regulations.

Education Requirement :

BSN or Associate's Degree with commitment to obtain BSN within 5 years of hire, required.

Licensure Requirement :

Registered Nurse in the State of Ohio, required.

Certifications : CPR, required.

Obtain and maintain NRP and PALS certification as determined by management.

Certification by the Association of Clinical Research Professionals or Society of Clinical Research Administrators.

Skills :

Understanding of medical terminology, clinical trials preferred

Working knowledge of PCs, word processing, and data management software

Strong verbal, written, interpersonal communication

Goal-oriented; self-directive, initiation, self-motivation, creativity, flexibility

Excellent organizational, attention to detail and prioritization skills

Ability to actively participate as a team player

Experience :

Two years in clinical research nursing, required.

Physical Requirements :

OCCASIONALLY : Bend / twist, Biohazard waste, Blood and / or Bodily Fluids, Chemicals / Medications, Climb stairs / ladder, Cold Temperatures, Color vision, Communicable Diseases and / or Pathogens, Depth perception, Driving motor vehicles (work required)

FREQUENTLY : Decision Making, Interpreting Data, Problem solving, Standing, Walking

CONTINUOUSLY : Audible speech, Computer skills, Hearing acuity, Repetitive hand / arm use, Sitting

Additional Physical Requirements performed but not listed above :

(not specified)

"The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision. EOE M / F / Disability / Vet"