Clinical Research Coordinator I-Center for Data-Driven Discovery in Biomedicine
About The Position
We are the Center for Data-Driven Discovery in Biomedicine (D3b - d3b.center), an ambitious and unique blend of experts in the field of pediatric brain tumor research. Our mission is to empower researchers to analyze biological and genomic data, so that they may discover insights that lead to cures or dramatically improved treatment options. We want creative problem solvers that are passionate about clinical research operations, biospecimen management and biobanking operations, and are excited to learn whatever is needed to empower our mission. As a Clinical Research Coordinator I, you will work with other study team members on project activities, primarily for consenting, clinical data management, biospecimen handling and accessioning, biospecimen data management, and quality control, for projects in our D3b portfolio.
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
- 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
- Manage essential regulatory documents
- Complete case report forms (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)
- Coordinate research/project team meetings
- Collect samples as applicable to the protocol such as saliva from subjects and relatives Schedule subject visits and procedures
- Retain records/archive documents after study close out
- Tracks biospecimens across platforms and performs biospecimen data entry
- Accessions biospecimens into a LIMS (Laboratory Information Management System) for integration into a biobank.
- Performs tasks that require familiarity with fundamental laboratory techniques and equipment, such as weighing tissue samples, evaluating specimens for deviations, handling biospecimens, and the storage of biospecimens
- Communicates with study collaborators about biobanking operations at CHOP and at external institutions
- Monitors supply levels at pathology and coordinates restocking supplies as needed
- Assists with planning specific research protocols and workflow optimization
- Provides required metrics for reports as needed
- Ensures all standard operating procedures and workflows are current and updated as needed
- Submits requests to the Biorepository Resource Center through iLab and coordinates execution of the requests
- Performs routine quality control on biospecimen inventory and data in the LIMS, specimen associations to patients in platforms, biospecimen documentation, and other biospecimen tracking
- Other biospecimen operational activities to support new research projects or initiatives as needed
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
Number of Employees
5,001-10,000 employees
