RN Clinical Research Coordinator - Gene Therapy

Socket.dev; Kentucky; On-site; USD 70,000 - 100,000; Full time

Job summary

Socket.dev is seeking a Registered Nurse to oversee patient care in a clinical research trial, ensuring safety and protocol adherence throughout participation. The role emphasizes evidence-based care planning and effective communication within the care team.

The RN must hold an Ohio license and have a BSN or be pursuing BSN within five years, with strong clinical nursing and data management skills. Some study-related responsibilities may require occasional on-site visits in Kentucky.

Qualifications

• Nursing qualifications and clinical trial familiarity.
• Excellent communication and documentation skills.
• Ability to work with diverse teams in study environments.

Responsibilities

• Plan and evaluate care plans using study protocols and evidence-based practices.
• Provide nursing care focused on patient safety and advocacy with a Family Centered approach.
• Coordinate with clinicians and ancillary staff to support trial participation and outcomes.
• Manage procedural, regulatory, and training elements for trial implementation and closeout.

Skills

Nursing skills

Communication

Teamwork

Data management

PC literacy

Education

BSN or Associate's with commitment to BSN

Tools

Electronic health records

Job description

Overview:

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.

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, preferred.

Skills:

• Demonstrated proficiency in clinical nursing skills, (i.e.: 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, 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:

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) *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

"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"