RN Clinical Research Coordinator - Gene Therapy

Monday-Friday, hours between 7:00a & 5:00p. One remote day per week, dependent on patient visits. Rare but possible Saturday/Sunday patient visits requiring 2-3 hours, based on study assignment.

About the role

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.

Responsibilities

• 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

Requirements

• BSN or Associate's Degree with commitment to obtain BSN within 5 years of hire, required
• Registered Nurse in the State of Ohio, required
• CPR certification, 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, preferred

Skills

• Demonstrated proficiency in clinical nursing skills (e.g., venipuncture, IV starts and injections)
• Understanding of medical terminology; clinical trials preferred
• Working knowledge of PCs, word processing, and data management software
• Strong verbal, written, and interpersonal communication
• Goal-oriented, self-directive, initiative, self-motivation, creativity, flexibility
• Excellent organizational, attention to detail, and prioritization skills
• Ability to actively participate as a team player

Experience

Clinical research experience, preferred.

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), electricity, flexing/extending of neck, fumes/gases/vapors, hand use (grasping, gripping, turning), hot temperatures, lifting/carrying (0-10 lbs, 11-20 lbs, 21-40 lbs, 41-60 lbs, 61-100 lbs), loud noises, patient equipment, peripheral vision, pushing/pulling (0-25 lbs, 26-40 lbs, 41-60 lbs, 61-100 lbs, 100 lbs or greater with assistance), reaching above shoulder, seeing (far/near), squat/kneel.

Frequently: Decision making, interpreting data, problem solving, standing, walking.

Continuously: Audible speech, computer skills, hearing acuity, repetitive hand/arm use, sitting.