Coordinator Research Nursing:
CHOP

15867-en_US
CHOP
Philadelphia Pennsylvania
Healthcare
Description

Req ID: 15867

Shift: Any

Employment Status: AF - Active - Regular - Full Time 

Job Summary

Performs any combination of the following for the purpose of conducting and monitoring clinical trials:
• Develop, coordinate and implement research and administrative strategies essential to the successful management of clinical trials 
• Prioritize and perform multiple tasks and ensure the execution and timely completion of assigned protocols.  
• Perform a variety of duties involved in the organization, oversight, documentation and compilation of clinical information and data.   

Job Responsibilities

1. Protocol Preparation/IRB Submission
•Assist in preparing protocol narrative for IRB submission.
•Prepare/revise protocol consent documents according to regulatory standards.
•Maintain accurate database, and files of all IRB communications.
•Preparation of annual or interim progress reports.
•Ensure timely reporting of severe adverse events according to regulations.
•Timely submission of protocol amendments and advisories according to regulations.
•Continual update and revision of databases.
•Conduct routine self-audit, ensuring appropriate study conduct. Communicate with staff if deficiencies are noted.
•Participates and helps organize Quality Assurance 
•Prepares site and medical records for regulatory audits.
 
2. Protocol Communication
•Protocol review to determine eligibility, pre-treatment requirements.
•Announce protocol opening, suspension, and closure. Ensure updated copies of protocol are distributed and maintained in key areas at CHOP and at the Hospital of the Univ., of Penn when appropriate.
•Serves as a liaison to CHOP investigators, nurses, pharmacists, surgeons, pathologists, and radiologists for information exchange regarding clinical trials.
•Patient and family education concerning NBDT studies
•Maintains for physicians, parent/patient, correct treatment plan (therapy roadmap). When necessary, develops tools such as calendars, fast fact sheets that assist in the delivery of treatment and aide in accurate protocol interpretation and compliance.
 
 

Job Responsibilities (Continued)

3. Study enrollment
•Ensures written consent obtained prior to treatment and enrollment.
•Clinically evaluates all patients and ensures only eligible subjects are enrolled.
•Source documents all eligibility and pre-treatment requirements prior to enrollment, as well as on going source documentation as appropriate to the research.
•Investigate study status of patient's referred for NBDT studies from outside facilities. 
 
4. Case management for timely Record Analysis; Abstraction; Data Submission.
•Analyze medical record and abstract pertinent data for completion of case report forms.
•Communicates with family and team to ensure accurate reporting of toxicity, complications and adverse events per protocol guidelines.
•Ensures timely data submission.
•Monitors compliance to trial. Communicates with physicians regarding deviations from protocol standards and/or treatment.
•Reviews medical record to ensure documentation is adequate for study validation and chart audits. Advise physician/nursing staff of appropriate documentation.
•Ensure required specimens are collected and shipped according to protocol guidelines.
•Provides study coverage for industry studies and PK trials necessitating blood draws or other bodily specimen.
•Works seamlessly with the Nurse Practitioners to schedule and is available for outpatient visits related to the protocols and routine follow-up. 
 
5. Continuing Education.
•Must maintain current clinical research certification. If not certified, will seek clinical research testing and certification within 2 years of hire. 
•Attends at least one annual Cooperative Group Clinical Research Workshop.

Job Responsibilities (Continued)

Required Licenses, Certifications, Registrations

None

Required Education and Experience

  • Graduate of National League for Nursing accredited school of nursing with a minimum of Bachelor’s degree or related healthcare field.
  • Able to work independently and interact with medical researchers and staff.

Preferred Education, Experience & Cert/Lic

  • Minimum of two years clinical research trial monitoring/coordination experience preferred.
  • SoCra (or equivalent) certification preferred. 

Additional Technical Requirements

  • Previous clinical research experience.  Successful performance in a high-intensity work environment.
  • Excellent problem identification and problem solving skills.
  • Attention to detail
  • Clinical assessment 
  • Excellent organizational skills required.
  • Ability to balance multiple priorities,
  • Excellent written and interpersonal skills.
  • Ability to handle confidential materials and matters.
  • Knowledge of IRB issues and guidelines, elements of informed consent, FDA codes and Regulatory Issues.

All CHOP employees who work in a patient building or who provide patient care are required to receive an annual influenza vaccine unless they are granted a medical or religious exemption.

Children's Hospital of Philadelphia is committed to providing a safe and healthy environment for its patients, family members, visitors and employees. In an effort to achieve this goal, employment at Children's Hospital of Philadelphia, other than for positions with regularly scheduled hours in New Jersey, is contingent upon an attestation that the job applicant does not use tobacco products or nicotine in any form and a negative nicotine screen (the latter occurs after a job offer).

Children's Hospital of Philadelphia is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability or protected veteran status.

VEVRAA Federal Contractor/Seeking priority referrals for protected veterans.  Please contact our hiring official with any referrals or questions.

CHOP Careers Contact 

Talent Acquisition

2716 South Street, 6th Floor

Philadelphia, PA 19146 

Phone: 866-820-9288 

Email:TalentAcquisition@email.chop.edu

 

 

Basic Qualifications
Requirement