Clinical Research Coordinator I for Health Policy and Economics

Children's Hospital of PhiladelphiaPhiladelphia, PA
Onsite

About The Position

The Neonatology Health Services Research group at Children’s Hospital of Philadelphia (CHOP) is seeking a full-time Clinical Research Coordinator (CRC) to contribute to their health policy and hospital financing studies. This role involves working closely with a team of principal investigators, post docs, statisticians, and other research coordinators. The CRC will be responsible for in-depth review of policies, assisting with dataset creation related to hospital ownership and finances, preparing and updating IRB paperwork, and developing familiarity with econometric methods. The ideal candidate will be a self-driven learner, detail-oriented, possess clear communication and problem-solving skills, and have a coursework background in public policy, economics, and statistics with an interest in health policy.

Requirements

  • High School Diploma / GED
  • At least two (2) years of clinical or research related experience
  • Basic knowledge of IRB and human subject protection
  • Strong verbal and written communications skills
  • Strong time management skills
  • Ability to collaborate with stakeholders at all levels

Nice To Haves

  • Bachelor's Degree
  • At least three (3) years of clinical or research related experience
  • Prior experience with health policy analyses and statistical coding (Stata, R)
  • Coursework background in public policy, economics, and statistics, as well as an interest in health policy

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 under the supervision of PI
  • 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, and with HIPAA and management of confidential materials
  • Comply with federal, state, and sponsor policies
  • For multi-site studies or collaborations, support communication and meeting scheduling across teams
  • Manage essential regulatory documents
  • Register study on ClinicalTrials.gov as appropriate
  • 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 as appropriate
  • Facilitate study close out activities as appropriate
  • Coordinate research/project team meetings
  • Collect, process and ship samples as applicable to the protocol
  • Schedule subject visits and procedures
  • Retain records/archive documents after study close out

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What This Job Offers

Job Type

Full-time

Career Level

Entry Level

Education Level

High school or GED

Number of Employees

5,001-10,000 employees

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