Clinical Research Coordinator I - Supportive Care in Oncology Research (SCORe)

SHIFT:Day (United States of America)

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A Brief Overview
The Supportive Care in Oncology Research (SCORe) program is seeking an energetic, organized, detail-oriented candidate. This position will support a Principal Investigator leading clinical and translational research focused on infectious complications associated with cellular therapy. The mission of the SCORe program is to conduct rigorous clinical and translational research that generates evidence to advance the prevention and treatment of infections. Through this work, the program aims to inform best practices and improve the health of children.

This role functions independently in a clinical research setting and is responsible for the complete coordination of specific clinical research projects, including clinical trials, observational, and data studies. This individual should have an interest in research related to the microbiome, infectious diseases, and viral illness in malignant and non-malignant transplant patients. This individual will perform all clinical research coordinator responsibilities, as detailed in the job responsibilities, working in collaboration with disease specific groups within the Center for Childhood Cancer Research (CCCR), Pediatric Infectious Disease Epidemiology & Antimicrobial Stewardship (IDEAS) group, and the Center for Microbial Medicine (CMM).

This role substantially coordinates all clinical research activities within the scope of clinical research protocols. Duties involve managing the day-to-day activities of the research study under the guidance of managing study staff and PI.

What you will do

• 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
• 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
• Related responsibilities
• 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

Education Qualifications

• High School Diploma / GED Required
• Bachelor's Degree Preferred

Experience Qualifications

• At least two (2) years of clinical or research related experience Required
• At least three (3) years of clinical or research related experience Preferred

Skills and Abilities

• 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

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. Learn more. EEO / VEVRAA Federal Contractor | Tobacco Statement

SALARY RANGE:

$53,000.00 - $66,300.00 Annually

Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly.

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At CHOP, we are committed to fair and transparent pay practices. Factors such as skills and experience could result in an offer above the salary range noted in this job posting. Click here for more information regarding CHOP's Compensation and Benefits.