Biospecimen Clinical Research Coordinator I - Precision Medicine
About The Position
A Clinical Research Coordinator position is open in the Center for Childhood Cancer Research (CCCR) at the Children’s Hospital of Philadelphia (CHOP) and the University of Pennsylvania (UPENN). This position is part of Center for Precision Medicine for High-Risk Pediatric Cancer’s biobanking operation. The goal is to bank clinically annotated frozen and viable patient specimen to support ongoing research efforts into understanding childhood cancer and to develop new therapeutic approaches. Supported projects include immunotherapy and targeted therapy preclinical studies, organoid and PDX models, and sophisticated molecular analysis of primary patient material. The candidate will be a member of the Precision Medicine for High-Risk Pediatric Cancer Team and will be primarily responsible for interfacing with clinical and pathology teams for the collection of blood, bone marrow and tumor material, and processing viable blood and tumor material. In addition, the candidate will partner with another clinical research coordinator to consent patients and for data entry. In addition, the candidate may have some involvement with PDX (patient derived xenograft) models. All these duties will require an individual who is willing to work with patients, patient samples as well as mouse tumor models. Ideal candidates will have great communication skills and meticulous attention to detail.
Requirements
- High School Diploma / GED Required
- At least two (2) years of clinical or research related experience Required
- Basic knowledge of IRB and human subject protection
- Strong verbal and written communications skills
- Strong time management skills
- Ability to collaborate with stakeholders at all levels
Nice To Haves
- Bachelor's Degree Preferred
- At least three (3) years of clinical or research related 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
- Under the supervision of PI 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, and with HIPAA and management of confidential materials
- Must comply with federal, state, and sponsor policies
- For multi-site studies or collaborations, support communication and meeting scheduling across teams
- Manage essential regulatory documents
- Register study on ClinicalTrials.gov as appropriate
- 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 as appropriate
- Facilitate study close out activities as appropriate
- Coordinate research/project team meetings
- Collect, process and ship samples as applicable to the protocol
- Schedule subject visits and procedures
- Retain records/archive documents after study close out
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
