Clinical Research Coordinator RN Lead- Gene Therapy

Overview:

Typical Schedule: Day Shift, Monday-Friday, 40 hrs/week

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:

Oversees the orientation, day to day supervision and continuing professional development of team members through ongoing guidance and support in all aspects of conducting clinical research projects. 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 a clinical research 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:

Works with Director to manage all human and physical resources associated with the research unit; Establishes performance, quality and training standards for CRS clinical staff to ensure all unit research is conducted in compliance with all regulations

Provides guidance/oversight to team members in all aspects of clinical study coordination as well as patient safety; troubleshoots clinical study issues including those issues that have operational, compliance and/or regulatory impact

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, required.

Licensure Requirement:

Registered Nurse in the State of Ohio, required.

Certifications:

CPR, required.

Must be willing to 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 or able to obtain within 6 months of hire.

Skills:

Demonstrated proficiency in clinical nursing and teaching clinical nursing skills such as venipuncture, IV starts, and injections

Understanding of medical terminology and 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

Ability to lead others; positive attitude; excellent problem-solving skills, highly effective critical thinking skills

Excellent organizational, attention to detail and prioritization skills

Demonstrated effective conflict management; provides feedback in a constructive way.

Experience:

Three years of clinical research nursing experience or equivalent clinical research, education, nursing, and supervisory/management experience, required.

Experience working in CRS, 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) *additional testing may be required, Electricity, Flexing/extending of neck, Fume /Gases /Vapors, Hand use: grasping, gripping, turning, Hot Temperatures, Lifting / Carrying: 0-10 lbs, Lifting / Carrying: 11-20 lbs, Lifting / Carrying: 21-40 lbs, Lifting / Carrying: 41-60 lbs, Lifting / Carrying: 61-100 lbs, Loud Noises, Patient Equipment, Peripheral vision, Pushing / Pulling: 0-25 lbs, Pushing / Pulling: 100 lbs or greater with assistance, Pushing / Pulling: 26-40 lbs, Pushing / Pulling: 41-60 lbs, Pushing / Pulling: 61-100 lbs, 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

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"

R-14001