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Clin Research Coordinator II

Philadelphia, PA, US, 19146

Job Type: 

Req ID: 25405

Shift: Days

Employment Status: AF - Active - Regular - Full Time 

Job Summary

Job Summary:

Dr. Kate Henry at the Center for Pediatric Clinical Effectiveness and Safe Place: The Center for Child Protection and Health is seeking a clinical research coordinator to join her team.

 

Dr. Henry conducts research addressing the medical evaluation of children who present for medical care with concerns for physical abuse.  Dr. Henry focuses on the imaging evaluation of these children, specifically assessing which children benefit most from certain imaging modalities.  Her current studies and initiatives assess spinal trauma, abdominal trauma, and fractures.  She conducts both prospective and retrospective studies.  The open position will involve work in these and related areas focused on child protection.

 

The Center for Pediatric Clinical Effectiveness is a pediatric research center dedicated to discovering and sharing knowledge about best practices in pediatric care by facilitating, organizing and centralizing the performance of clinical effectiveness research – research aimed at understanding the best ways to prevent, diagnose, and treat diseases in children. CPCE’s multidisciplinary team conducts research on a diverse range of clinical effectiveness topics.

 

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

Job Responsibilities

The ideal candidate will have a master’s degree in a health-related field, experience in using STATA software, and prior research experience that includes review of medical records. The candidate will work in a supported and collegial research environment and will be expected to work comfortably in a research team. 

 

The successful applicant should have strong writing, organizational, analytical, and interpersonal skills as well as flexibility to work on a variety of projects.  Responsibilities will include participation in grant writing, protocol development, conducting literature reviews, approaching families for participation in studies, managing IRB applications and amendments, database creation and management (through REDCap), and detailed medical record reviews.   

 

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

 

 

Job Responsibilities (Continued)

Job Responsibilities (Continued)

Required Licenses, Certifications, Registrations

Required Education and Experience

 

Required Education: Bachelor’s Degree in related field

 

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

Preferred Education, Experience & Cert/Lic

Preferred Education: Master’s degree in a related field

 

Preferred Experience: One (1) year relevant 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

 

 

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

 

 

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