Clin Research Coordinator II - Cellular Therapy and Transplant Section (CTTS) 65003
Location:
LOC_WOOD_CTR-Wood Building
Req ID:
87017
Shift:
Days
Employment Status:
Regular - Full Time
Job Summary
The CHOP Cellular Therapy and Transplant Section (CTTS)is seeking candidates with relevant clinical research experience in oncology, gene-modified cellular therapy, and/or hematopoietic progenitor cell transplant.
Candidates must have knowledge and skills in clinical trial management including regulatory knowledge such as Good Clinical Practices.
The position will support the research efforts for our patient populations receiving lifesaving therapies for a variety of malignant and non- malignant diseases.
Patients are offered treatments on open and accruing research protocols.
CHOP has close clinical research and clinical practice collaborations with an NCI-designated comprehensive cancer center at the adjacent Hospital of the University of Pennsylvania's Abramson Cancer Center.
This position will support our section s participation in the Center for International Blood and Marrow Transplant research (CIBMTR).
This requires timely and accurately submission of patient data which makes outcomes available to the public.
CTTS is one of the most active pediatric cell therapy programs in the world.
The successful candidate will be joining a group providing outstanding clinical services and performing cutting edge clinical and translational research focused on alternative donor transplants, CAR T cells, and other cell therapies.
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.
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
Required
Experience:
Three (3) years of clinical research coordination experience.
Preferred Education, Experience & Cert/Lic
Preferred Education:
Master s degree in a related field
Preferred
Experience:
Five (5) years of 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.
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
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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