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24 Feb 2021

Full-Time Clinical Research Coordinator I

Children’s Hospital of Philadelphia – Posted by schroedern Philadelphia, Pennsylvania, United States

Job Description

Job Summary

This position is seeking a Clinical Research Coordinator (CRC) for clinical research in Late Effects of Childhood Cancer Therapy conducted within the CHOP healthcare network. The Principal Investigator (PI) is a double-boarded physician in Pediatric Oncology & Pediatric Endocrinology with a NIH-funded research program focused on addressing endocrine late effects in childhood cancer survivors.

 

The ideal candidate would be interested  in research related activities such as confirmation of subject eligibility, recruitment, enrollment and informed consent of study subjects; preparation of study packets, study visit scheduling, accompanying research subjects for their clinical research visits; completion of study case report forms; data clarification, collection, abstraction, storage and entry; serving as PI liaison with other research groups; participation in grant related meeting with PI to gain better understanding of protocol issues and development; responsible for meeting enrollment projections within study-specified time lines; IRB submissions, amendments, and continuing reviews; oversight of regulatory requirements, preparation of research reports and manuscripts; data analysis under PI guidance; assistance with preparing research grants, literature reviews and article retrieval; maintenance of endnote or related literature libraries; completion of CITI training if selected for the position.

 

This position provides great research opportunity, mentorship by PI, and valuable experience for candidates with a strong interest in pursuing a future professional position within the healthcare-related field (medical school or graduate school). The PI has had multiple funded grants providing an exciting and terrific opportunity to conduct high quality clinical research in a supportive and collegiate work environment.

 

Job Responsibilities

Core responsibilities

  • Adhere to an IRB approved protocol
  • Participate in the informed consent process of study subjects
  • Support the safety of clinical research patients/research participants
  • Coordinate protocol related research procedures, study visits, and follow-up care
  • Screen, recruit and enroll patients/research participants
  • Maintain study source documents
  • Report adverse events
  • Understand good clinical practice (GCP) and regulatory compliance
  • Educate subjects and family on protocol, study intervention, etc.
  • Comply with Institutional policies, standard operating procedures (SOPs) and guidelines
  • Must comply with federal, state, and sponsor policies

 

Related responsibilities

  • Manage essential regulatory documents
  • Register study on ClinicalTrial.gov
  • Complete case report forms (paper & electronic data capture) and address queries
  • Submit documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (ie, DSMB, independent safety officer)
  • Facilitate pre-study, site qualification, study initiation, and monitoring visit
  • Facilitate study close out activities
  • Coordinate research/project team meetings
  • Collect, process and ship laboratory specimens
  • Schedule subject visits and procedures
  • Retain records/archive documents after study close out

Job Responsibilities (Continued)

Job Responsibilities (Continued)

Required Licenses, Certifications, Registrations

Required Education and Experience

Required Education:

  • Associates Degree or active enrollment in a Bachelor’s Degree Program

 

Required Experience:

  • Three (3) years of coordination related, clinical related or research related experience.

Preferred Education, Experience & Cert/Lic

Preferred Education: Bachelor’s Degree in related field

Additional Technical Requirements

  • Excellent verbal and written communications skills
  • Excellent time management skills
  • Ability to collaborate with stakeholders at all levels
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How to Apply

https://careers.chop.edu/job/Philadelphia-Clin-Research-Coordinator-I-65002-PA-19104/715122100/

Job Categories: Equal Opportunities. Job Types: Full-Time.

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