Clinical Research Assistant II- Chou Lab

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A Brief Overview
Under the direct supervision of the Principal Investigator and/or other study team members, this role provides experienced support in the conduct of clinical research.

Job responsibilities may include human subject research activities including but not limited to subject enrollment, data/sample collection, data entry, and regulatory submissions support.

About the lab:

Dr. Stella Chou is 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 hemoglobinopathies by using genomics to identify risk of alloantibody formation and selecting compatible red cell donors.

Her research program is currently seeking a full-time clinical research assistant 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.

What you will do

• Providing technical and clinical support in the conduct of clinical studies:
• Filing and office organization
• Patient/research participant scheduling
• Patient/research participant history
• Data collection/extraction from electronic medical record systems and entry into project databases and platforms
• Data management, including assisting with quality control and data review
• Laboratory procedures
• Research Study Compliance
• Adhere to IRB approved protocols and compliance with HIPAA and handling confidential materials
• Support the safety of clinical research patients/research participants
• Comply with Institutional policies, SOPs and guidelines
• Comply with federal, state, and sponsor policies
• Additional Responsibilities may include:
• Participate in the informed consent process for study subjects
• Document and report adverse events
• Maintain study source documents
• Submit basic IRB reports
• Assist with IRB/regulatory submissions
• Complete case report forms (paper and electronic data capture)
• Follow-up care
• Order materials/supplies
• Schedule research meetings

Related responsibilities

• Manage essential regulatory documents
• Maintain study on ClinicalTrial.gov
• Complete case report forms (paper & electronic data capture) and address queries
• Submit documents to regulatory authorities (e.g. IRB) and/or review/monitoring boards (ie, DSMB)
• 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
• 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

Education Qualifications

• High School Diploma / GED - Required
• Bachelor's Degree - Preferred

Experience Qualifications

• At least one (1) year of relevant clinical research experience - Required
• At least two (2) years of relevant clinical research experience - Preferred

Skills and Abilities

• Basic knowledge of IRB and human subject protection.

To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must receive an annual influenza vaccine. Learn more.

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SALARY RANGE:

Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly.

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At CHOP, we are committed to fair and transparent pay practices. Factors such as skills and experience could result in an offer above the salary range noted in this job posting. Click here for more information regarding CHOP's Compensation and Benefits.