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Clinical Research Coordinator II - Hematology

Philadelphia, PA, US, 19104

Job Type: 

Req ID: 26261

Shift: Days

Employment Status: AF - Active - Regular - Full Time 

Job Summary

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

The Clinical Research Coordinator will work under the direction of Dr. Stella Chou a pediatric hematologist and transfusion medicine specialist whose research aims to improve transfusion therapy for patients with sickle cell disease (SCD) and thalassemia who require chronic transfusion therapy but often form complex antibodies to transfused red cells. Her work has shown that Rh alloimmunization in patients is associated with inheritance of variant RH genes. Current projects aim to examine whether “genetic-matching” of blood for patients is feasible and identifying new risk factors for alloimmunization in these patient populations. Her laboratory is focused on alloimmunization prevention and transfusion safety for patients with hemoglobinapathies by using genomics to identify risk of alloantibody formation and selecting compatible red cell donors.

 

 

Her research program is currently seeking a full-time research clinical coordinator to interact with patients, be involved with the informed consent process, facilitate specimen collection for laboratory studies, organize clinical data in an electronic database, assist in analyzing data, and contribute to manuscript preparation.

 

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

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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