Clinical Research Assistant II -Neurosurgery & the Center for Data Driven Discovery
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. Providing technical and clinical support in the conduct of clinical studies: Collects and delivers intraoperative specimens to pathology and research laboratories, ensuring accurate documentation and compliance with regulatory standards Participate in the informed consent process for study subjects Maintain study source documents Filing and office organization Data collection/extraction from EPIC (electronic medical record system) and entry into project databases and platforms Data management, including assisting with quality control and data review Assist with the redaction of pathology, operative, or MRI reports Schedule research meetings and rooms when needed Comply with Institutional policies, study SOPs and guidelines Must comply with federal, state, and sponsor policies Submit basic IRB reports Must possess knowledge of IRB and human subject protection and must adhere to an IRB approved protocol (through Citi Program Certification performed following hiring) Other tasks as assigned
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.
- To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must receive an annual influenza vaccine.
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
- Collects and delivers intraoperative specimens to pathology and research laboratories, ensuring accurate documentation and compliance with regulatory standards
- Participate in the informed consent process for study subjects
- Maintain study source documents
- Filing and office organization
- Data collection/extraction from EPIC (electronic medical record system) and entry into project databases and platforms
- Data management, including assisting with quality control and data review
- Assist with the redaction of pathology, operative, or MRI reports
- Schedule research meetings and rooms when needed
- Comply with Institutional policies, study SOPs and guidelines
- Must comply with federal, state, and sponsor policies
- Submit basic IRB reports
- Must possess knowledge of IRB and human subject protection and must adhere to an IRB approved protocol (through Citi Program Certification performed following hiring)
- Patient/research participant scheduling
- Patient/research participant history
- Adhere to IRB approved protocols and compliance with HIPAA and handling confidential materials
- Support the safety of clinical research patients/research participants
- Assist with IRB/regulatory submissions
- Complete case report forms (paper and electronic data capture)
- Follow-up care
- Order materials/supplies
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
