Clinical Research Coordinator II - IMPACT-IRD

Children’s Hospital of Philadelphia•Philadelphia, PA

5d•$56,890 - $71,110•Onsite

About The Position

The Children's Hospital of Philadelphia Cellular Therapy and Transplant Section (CTTS) is seeking candidates with relevant experience to join our clinical research team! Your work will directly impact our families journey. We offer a unique and exciting multi-disciplinary environment in which to work. Applicants for this position must have demonstrated excellent qualifications, be able to work independently, be flexible and want to work in a team. CTTS treats a variety of diseases utilizing hematopoietic progenitor cells (HPC), genetically modified HPC and immune effector cells (IEC). Diseases treated include certain types of cancer, disorders of the blood and immune system as well as a wide variety of other rare disorders and syndromes. This position will be responsible for supporting research studies in these key treatment areas with special focus on diseases that involve immune system dysregulation. We offer a competitive salary and take mentorship and career growth seriously. We are a mission-oriented team that needs and rewards great talent. The successful candidate will be part of the CTTS multidisciplinary team that implements outstanding cutting edge clinical, translational and outcomes research while providing outstanding clinical care to the patients and families we serve. Areas of research include alternative donor transplants, gene therapy, CAR T cells, and other novel cellular therapies including viral CTLs for treatment of variety viral diseases. Strong communication and organizational skills are necessary for this position as well as the ability to multitask and work in a fast passed often demanding environment. This position will be Monday-Friday and the shift will be dependent upon the operational need. Function independently in a clinical research setting, responsible for the complete coordination of assigned clinical research activities.

Requirements

Bachelor's Degree - Required
At least two (2) years of clinical/research coordination experience - Required
Basic knowledge of IRB and human subject protection
Excellent verbal and written communications skills
Strong time management skills
Ability to collaborate with stakeholders at all levels

Nice To Haves

Master's Degree in a related field - Preferred
At least three (3) years of clinical/research coordination experience - Preferred

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
Prepare, manage, submit, and maintain essential regulatory documents (e.g. IRB, FDA, etc.) and remain aware of the regulatory status for projects within scope of role
Register study on ClinicalTrial.gov as appropriate
Complete case report forms (paper & electronic data capture) and address queries
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 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
Develop advertisement materials
Act as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals
Organize and/or run study-related meetings locally or across teams (for multi-site projects)
Support study team communications and outreach
Provide training to junior staff on conduct of research studies
Document investigational product (drug/device) accountability
Self-monitor and self-audit responsibilities
Develop informed consent document and/or draft or edit IRB protocols or related documents such as study administration manuals
Maintain Clinical Trial.gov
Develop Case Report Forms
Assignments to include more complex studies