Experience:
1-3 years of experience
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Employment Type:
Full time
Posted:
8/18/2017
Job Category:
Research
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Clin Research Coordinator I - Division of Gastroenterology Hepatology and Nutrition
CHOP | Philadelphia, Pennsylvania
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Job Description

Job Summary

Under moderate supervision, coordinates all clinical research activities within the scope of clinical research protocols.

•             Responsible for the coordination of clinical research activities conducted within the CHOP healthcare network.

•             Works with moderate supervision by a senior CRC or a clinical team supervisor and within the scope of clinical research protocols, participates in research activities which may include: subject recruitment, confirmation of subject eligibility, informed consent process, completion of case report forms, data clarification, IRB preparations, chart abstraction, hosting monitor visits, hosting site initiation visits.

•             Expected to meet enrollment projections within study-specified times.

•             Participates in in-services on floors with assistance of a more senior coordinator.

•             Will be encouraged to attend one related CCD class on an annual basis

•             Will be fully trained on good clinical practices (GCP) and regulatory responsibilities and will be held accountable for adherence to all policies and procedures surrounding this process and for maintaining up to date knowledge on these policies from IRB, FDA, ICH, GCP, or other sources. 

Job Responsibilities

The CRC I is expected to perform all CRC Core responsibilities (as applicable):

  • 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.

 

Also may be responsible for any of the following:

  • 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 visits
  • 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                                                                                                                                                               

Required Licenses, Certifications, Registrations

Preferred Education, Experience & Cert/Lic

Preferred Education:  BA/BS in a related field

Preferred Experience:  2+ year(s) relevant clinical research experience

Additional Technical Requirements

Requires effective writing and communication, work as part of a team, ability to multitask

About CHOP

About The Children's Hospital of Philadelphia: The Children's Hospital of Philadelphia was founded in 1855 as the nation's first pediatric hospital. Through its long-standing commitment to providing exceptional patient care, training new generations of pediatric healthcare professionals and pioneering major research initiatives, Children's Hospital has fostered many discoveries that have benefited children worldwide. Its pediatric research program is among the largest in the country, ranking third in National Institutes of Health funding. In addition, its unique family-centered care and public service programs have brought the 430-bed hospital recognition as a leading advocate for children and adolescents.

This company profile was created by AfterCollege and is about CHOP. This page is not endorsed by or affiliated with CHOP. For questions regarding company profiles, please email: care@aftercollege.com.