Clinical Research Assistant II- Chou Lab

Children’s Hospital of Philadelphia•Philadelphia, PA

1d•$23 - $28

About The Position

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.

Requirements

High School Diploma / GED - Required
At least one (1) year of relevant clinical research experience - Required
Basic knowledge of IRB and human subject protection.

Nice To Haves

Bachelor's Degree - Preferred
At least two (2) years of relevant clinical research experience - Preferred

Responsibilities

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
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
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
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