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Clinical Research Coordinator II

Philadelphia, PA, US, 19104

Job Summary

We are looking for a highly motivated CRC II to coordinate a national, collaborative multi-site, longitudinal study on the progression of Huntington’s Disease (www.changehd.org) at CHOP’s, Lurie Family Foundations Imaging Center. You will use your experience of human subject research and GCP skills to collaborate with a multidisciplinary team led by Dr. Timothy Roberts. As the CRC II, you will be relied on to lead with minimal supervision all aspects of the ChANGE HD research study. You will represent the study to the public and have strong interpersonal skills that bolster recruitment and sustain participant engagement. Some travel locally and nationally may be required as you collaborate with other research sites and promote the study at HD community events, clinics, and support groups. A strong professional with demonstrated efficiency and competent skill mastering in recruitment, research compliance, documentation, and study organization, will be well prepared for advancement to a CRC III and future project management responsibilities.

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

 

Also may be responsible for any of the following:

  • Manage study finances including sponsor invoicing & resolving study subject billing issues
  • Develop advertisement materials
  • Act as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals
  • Document investigational product (drug/device) accountability
  • Self-monitor and self-audit responsibilities
  • Develop informed consent document
  • Maintain Clinical Trial.gov 
  • Develop Case Report Forms
  • Assignments to include more complex studies

Required Education and Experience

Required Education: Bachelor’s Degree

 

Required Experience: Three (3) years of clinical research coordination experience.

Preferred Education, Experience & Cert/Lic

Preferred Education: Master’s degree in a related field

 

Preferred Experience: Five (5) years of clinical research coordination experience

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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Nearest Major Market: Philadelphia

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